All articles tagged: News Alert

The development marks the fifth approved indication of the drug since October 2023.

The European Medicines Agency has refused marketing authorizations for an herbal medicine intended to treat alopecia areata and a hybrid drug for neuroblastoma in children.

Use of the immunosuppressant injection has been recommended under exceptional circumstances.

Use of the immunosuppressant injection has been recommended under exceptional circumstances.

Two kinase inhibitors have been recommended by the European Medicines Agency for the treatment of non-small cell lung cancer.

The European Medicines Agency re-examined clinical data of a subset of patients with one or no copies of the APOE4 gene variant.

Obe-cel was designed to increase T-cell persistence and reduce T-cell exhaustion and was shown to improve response rates and survival, particularly in patients with low leukemia burden.

The new warning affects labels for drugs made with semaglutide, liraglutide, and tirzepatide.

The new warning affects labels for drugs made with semaglutide, liraglutide, and tirzepatide.

The FDA continues to approve new drugs and expand indications for others at a rapid pace. Here’s a summary of what happened last month.

The European Commission fined Teva for abusing its dominant position to delay competition for its multiple sclerosis drug Copaxone.

In a complete response letter, the FDA cited minor deficiencies related to drug substance, product, manufacturing and microbiology in the company’s abbreviated new drug application for ketamine.

This marks the product’s fourth approved indication.

The FDA placed the hold on the phase 3 PRESERVE-003 trial of the antibody candidate due to varying results between patient populations, according to an SEC notice.

This FDA approval marks the first for a claudin 18.2–targeting agent in the United States.

Vyalev (AbbVie) is the first and only subcutaneous 24-hour continuous infusion of levodopa-based therapy to address motor fluctuations in advanced Parkinson’s disease.

Europe’s drug regulator recommended two novel vaccines for influenza alongside updated composition for two COVID-19 vaccines previously approved by the EC.

The European Medicines Agency recommended the antihemorrhagic drug eltrombopag to treat forms of thrombocytopenia and aplastic anemia.

EMA re-evaluated data for Masitinib for the treatment of amyotrophic lateral sclerosis and Translarna for Duchenne, confirming its initial refusals.

The new buprenorphine formulation is used as a substitution treatment in adults and adolescents 15 years or older who agree to be treated for addiction.

The European Medicines Agency has recommended Korjuny for the treatment of patients with intraperitoneal malignant ascites.

Siiltibcy compared favorably with other diagnostic products for detecting Mycobacterium tuberculosis infection.

In a second letter to users of MiniMed 600 and 700 series insulin pumps, the company advises patients to carry backup batteries and change them immediately when “low battery pump” alert appears.

Lumryz is the only FDA-approved once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness in children as young as 7 years with narcolepsy.

The drug is approved for multiple inflammatory conditions and is expected to launch in the first half of 2025.

In the approval trial, Genentech's PI3K inhibitor doubled progression-free survival compared with placebo.

In average-risk adults, Cologuard Plus demonstrated sensitivities of 95% for CRC and 43% for advanced precancerous lesions at 94% specificity in the pivotal BLUE-C trial.

The FDA has approved a first-in-class antipsychotic that targets cholinergic receptors without blocking dopamine receptors.

Approval follows priority review granted based on findings from the LAURA trial.

The drug is the first and only dual IL-17A and IL-17F inhibitor approved to treat four chronic immune-mediated inflammatory diseases.

The CD38 antibody shows improved progression-free survival when added to standard treatment.

Amivantamab plus chemo is now indicated in locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations after disease progression on or after an EGFR-TKI.

The EMA has approved Penbraya for protection against invasive meningococcal disease and an update of the composition of two COVID-19 vaccines.

Hetronifly in combination with chemotherapy was shown to improve survival of patients with extensive stage small cell lung cancer, the European Medicines Agency said.

The drug will be available for patients aged 12 years and older and weighing at least 35 kg.

The drug will be available for patients aged 12 years and older and weighing at least 35 kg.

The European Medicines Agency approved Afqlir and Opuviz to treat age-related macular degeneration while reiterating its refusal of marketing authorization for Syfovre.

Elahere was found to improve survival in patients with FR-alpha–positive, platinum-resistant, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.

With more than 200 mpox-related deaths reported globally, the EMA has approved Imvanex for adolescents aged 12-17 years.

Unlike rival CDK 4/6 inhibitor abemaciclib, patients don't need to be lymph-node positive to receive ribociclib after surgery.

The blockbuster PD-1 inhibitor now has indications across 21 malignancies.

In a clinical trial, nearly 60% of participants achieved remission and 41% fully tapered off oral corticosteroids.

Subcutaneous injections save time, taking about 7 minutes, vs 30-60 minutes for intravenous infusion.

More than 1000 people age 12 years and older were enrolled in pivotal trials of the IL-13 inhibitor.

Subcutaneous administration of ocrelizumab was noninferior to intravenous infusion in the phase 3 OCARINA II trial.

The agency sent Regeneron a complete response letter based on findings from a preapproval inspection, which will delay the potential approval of its myeloma drug, linvoseltamab.

The combination is now approved in the frontline for locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations.

This approval follows recent concerns from an FDA committee that AstraZeneca did not demonstrate that patients needed the immunotherapy both before and after surgery.

The first-in-class treatment for chronic graft-versus-host disease is indicated for adult and pediatric patients weighing at least 40 kg.

Livdelzi significantly improves liver biomarkers of disease activity and bothersome symptoms of pruritus in adults with primary biliary cholangitis.

The treatment will benefit certain patients with primary advanced or recurrent endometrial cancer.

The interleukin-31 inhibitor is also under FDA review for treating atopic dermatitis.

Palopegteriparatide (Yorvipath) is a prodrug of parathyroid hormone administered once daily to provide stable PTH levels over 24 hours.

The US Food and Drug Administration has declined to approve MDMA-assisted therapy for the treatment of PTSD.

An epinephrine nasal spray to treat serious allergic reactions may soon be available in the United States.

The agent, which has returned to the US market in a reformulated version, is indicated for adults with relapsed or refractory stage 1-3 disease.

Zurnai, from Purdue, is the first nalmefene hydrochloride auto-injector for known or suspected opioid overdose in people aged 12 years and older.

The approval marks the first for a targeted therapy for grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation.

The afami-cel approval marks the first for an engineered T-cell receptor therapy targeting a solid tumor; the therapy was approved for adults with unresectable or metastatic synovial sarcoma.

The expanded approval is based on improved survival outcomes observed in the RUBY trial population of patients with advanced or recurrent disease.

The combination was approved for induction and consolidation in transplant-eligible patients with newly diagnosed multiple myeloma.

The agency says there's a problem with the latest trial of perioperative immunotherapy for NSCLC: There's no way to tell whether people need to continue treatment after surgery.

The US Food and Drug Administration alerted clinicians, compounders, and patients about adverse events related to compounded semaglutide dosing errors.

Existing advice for prescribing the weight loss drugs needs to be strengthened to minimize the risks from interactions, the European drug authority said.

The European Medicines Agency said there were exceptional circumstances for approving Kayfanda to treat pruritus in patients with the rare genetic disorder.

The drug downregulates immune and inflammatory responses in cells linked to the disease pathology.

The pivotal phase 3 trials enrolled 1223 adults in the United States, Canada, and Europe.

Leqembi's EU-wide marketing authorization was refused because the drug's effect on delaying cognitive decline does not counterbalance the risk for serious adverse events.

Iqirvo can delay liver fibrosis and cirrhosis in patients with primary biliary cholangitis, the European Medicines Agency decided.

The biosimilars, Bkemv and Epysqli, are also indicated for atypical hemolytic uremic syndrome.

The biosimilars, Bkemv and Epysqli, are also indicated for atypical hemolytic uremic syndrome.

Voquezna was shown to be safe and effective for relief of heartburn associated with nonerosive reflux disease in the phase 3 PHALCON-nonerosive GERD-301 study.

An updated review by the US Food and Drug Administration found multiple deaths associated with the ventilator recall.

Approval was based on results from three phase 3 studies, a phase 2 dose-ranging study, and two phase 1 pharmacokinetic trials.

The FDA has approved the anti-amyloid donanemab for early symptomatic Alzheimer's, which includes MCI or mild dementia stage of disease, with confirmed amyloid pathology.

The biosimilar is approved for all indications of the reference medication, Stelara, and will launch in February 2025.

Moderna's mRNA vaccine mRESVIA has been recommended for a marketing authorization in the EU to protect against respiratory syncytial virus in older adults.

The positive opinions pave the way for new treatment options in Europe for urothelial carcinoma, prostate cancer, lymphoma, and leukemia.

Drugs for ALS, age-related macular degeneration, and Duchenne muscular dystrophy did not get the green light due to lack of evidence.

Winrevair improves exercise capacity in patients with the condition while taking background therapy.

A nasal spray could help overcome obstacles to using autoinjectors for rapid treatment of anaphylaxis, the European Medicines Agency said.

The new approval follows the BiTE's first approval in 2023 for DLBCL.

The European Commission has authorized the use of Fruzaqla as a monotherapy for previously treated adult patients with metastatic colorectal cancer.

Approval of the topical anticholinergic was based on two phase 3 trials that enrolled 710 patients.

This marks the first approval for a KRAS inhibitor to treat CRC.

Altuvoct is used to treat and prevent bleeds and for perioperative prophylaxis in people of all ages with hemophilia A.

The approval is based on positive results from the phase 3 CAPItello-291 trial.

The approval is the fourth indication for the anti–interleukin 23 monoclonal antibody after approval for Crohn's disease, psoriatic arthritis, and plaque psoriasis.

The new vaccine covers eight serotypes not protected by other vaccines already on the market.

The approval for mismatch repair deficient newly diagnosed advanced or recurrent endometrial cancer was based on improved progression-free survival vs placebo across 95 women.

The new accelerated approval for the TKI was based on the overall response rate in 48 patients.

The approval applies to patients weighing ≥ 63 kg, the announcement said.

Iqirvo (elafibranor) is indicated for adults with primary biliary cholangitis who do not respond to or cannot tolerate ursodeoxycholic acid.

Approval was based on a phase 3, open-label study of adults with AKs.

The approval for the first-in-class agent is "potentially practice changing" given the lack of treatment options for transfusion-dependent lower-risk MDS patients.

The JAK inhibitor's safety profile for patients as young as 2 years was similar to known to the known safety profile in adults.

For the first time, an mRNA vaccine has been approved for an indication other than COVID-19. The vaccine will join a couple other immunizations currently on the market for respiratory syncytial virus.

Treatment of insulin-induced hypoglycemia with Zegalogue reduced recovery time from severe hypoglycemia, the European Medicines Agency said.

The drugs include an anti–PD-L1 monoclonal antibody, a biosimilar, and five generics, with indications covering a wide spectrum of cancers.

Previously, the EU protected against Creutzfeldt-Jakob disease transmission by banning blood donations from those who lived in the UK during its 1980s "mad cow" era.

The European Medicines Agency has given the go-ahead for Durveqtix to treat hemophilia B in adults and to Adzynma for patients with congenital thrombotic thrombocytopenic purpura.

Ixchiq is the first vaccine for protection against chikungunya to be recommended for European Union countries.

The centrally acting alpha2-adrenergic agonist allows for nighttime dosing and can be used with stimulants, the drug's manufacturer says.

This enables at-home administration of the medication, which was previously available only via intravenous infusion.

The drug company voluntarily requested the withdrawal of infigratinib, citing challenges enrolling patients for the required confirmatory postmarketing trials.

Continued approval of the first-in-class bispecific T-cell engager (BiTE) may depend on proof of clinical benefit.

The overall response rate to the CAR T therapy was 95.7% in phase 2 testing.

The recall warns of a software glitch with the t:connect mobile app that can lead to battery failure of the t:slim X2 insulin pump.

Relative to fecal immunochemical testing, the multitarget stool RNA test ColoSense showed a significant improvement in sensitivity for colorectal cancer and advanced adenomas.

Unlike the low-concentration formulation of adalimumab-adbm, launched July 1, 2023, this high-concentration version has not yet been granted an interchangeability designation.

The US Food and Drug Administration has approved pivmecillinam (Pivya) tablets to treat uncomplicated urinary tract infections in women.

European Union marketing authorization recommended for Altuvoct for hemophilia A caused by factor VIII deficiency.

Obgemsa is suitable for treating symptoms of an overactive bladder in adults, the European Medicines Agency has determined.

New restrictions have been imposed by the European Medicines Agency on the coadministration of the anti-HIV drug atazanavir with a variety of other agents.

The drugs are intended to treat several types of arthritis, psoriasis, COVID-19, and Crohn's disease.

The European Medicines Agency has recommended Fruzaqla, Truqap, and Eribulin Baxter for use in the treatment of specific colorectal and breast cancers.

Pfizer reported a list price of $3.5 million for its new gene therapy, Beqvez, for adults with this rare bleeding disorder.

The factor D inhibitor danicopan has been approved for use in Europe for patients with paroxysmal nocturnal hemoglobinuria with residual hemolytic anemia on standard therapy.

The first-in-class agent is approved alongside bacillus Calmette-Guérin to treat certain non–muscle-invasive bladder cancers that do not respond to bacillus Calmette-Guérin alone.

The approval makes alectinib the first ALK inhibitor approved for early-stage NSCLC.

Subcutaneous administration of vedolizumab is now approved for maintenance therapy in adults with moderate to severe active Crohn's disease after induction therapy with intravenous vedolizumab.

The biosimilar is expected to be marketed in the United States on or after February 21, 2025.

Reactions have included blurry vision, double vision, drooping eyelids, difficult swallowing or breathing, and other symptoms of botulism.

The first-ever AI diagnostic tool for sepsis was granted marketing authorization through the FDA's De Novo pathway.

The maintenance treatment for severe asthma with an eosinophilic phenotype originally was approved for patients aged 12 years and older.

Becton Dickinson said on Thursday the FDA cleared its finger-prick blood collection device that could provide a less-invasive option for some commonly ordered lab tests.

Vivos Therapeutics said on Wednesday the US health regulator has cleared its oral device for severe obstructive sleep apnea, leading a massive rally in the company's shares before the bell.

The FDA has determined that the risk for lymphoma and other T-cell cancers may apply to approved BCMA- and CD-19–directed CAR T-cell immunotherapies.

Levetiracetam and clobazam can cause a rare but serious drug reaction with eosinophilia and systemic symptoms that can be life threatening if not diagnosed and treated quickly, the FDA warns.

The new colony-stimulating factor from China proved comparable to pegfilgrastim (Neulasta) in clinical testing.

The new colony-stimulating factor from China proved comparable to pegfilgrastim (Neulasta) in clinical testing.

This is the first drug approved to treat desmoid tumors.

After a mixed FDA panel review in August, the agency has approved Medtronic's Symplicity Spyral renal denervation system for treatment of hypertension.

The expanded approval makes enzalutamide the first and only approved androgen receptor signaling inhibitor in the nonmetastatic castration-sensitive prostate cancer setting.

Adding pembrolizumab to chemotherapy had significant benefits in patients with locally advanced unresectable or metastatic, HER2-negative gastric or gastroesophageal junction adenocarcinoma.

The first-in-class AKT inhibitor administered with fulvestrant prolonged PFS vs fulvestrant alone in patients with PIK3CA/AKT1/PTEN-altered tumors.

The next-generation tyrosine kinase inhibitor provides a new treatment option for patients with this difficult-to-treat form of lung cancer.

Adzynma is the first treatment to become available for patients with congenital thrombotic thrombocytopenic purpura.

This marks the first approval for the oral anti-VEGFR tyrosine kinase inhibitor.

Tirzepatide, the active ingredient in Eli Lilly’s Zepbound, is already approved under the name Mounjaro for the treatment of type 2 diabetes.

Now-discontinued "Dr. Ergin's SugarMD Advanced Glucose Support" was found to contain glyburide and metformin, which are only available by prescription.

Vonoprazan (Voquezna) is indicated for the healing and maintenance of healing of all grades of erosive esophagitis, as well as relief of associated heartburn in adults.

The new approval is the sixth gastrointestinal indication for the checkpoint inhibitor.

The drug has also been granted an interchangeability designation and has been approved for six indications.

This marks the second FDA-approved agent for the condition, and the first IL-17A inhibitor.

This marks the first approval for toripalimab.

The Alltest fentanyl urine test provides a preliminary result; a more specific alternative chemical method, confirmation testing, is required to confirm the result.

Mirikizumab (Omvoh) is the first IL-23 inhibitor to be approved in the United States for the treament of moderately to severely active ulcerative colitis.

Mirikizumab (Omvoh) is the first IL-23 inhibitor to be approved in the United States for the treament of moderately to severely active ulcerative colitis.

Vamorolone (Agamree) is a structurally unique steroidal anti-inflammatory drug with fewer side effects than traditional corticosteroids.

Certain products may contain active ingredients found in prescription-only drugs.

The product combines an antibiotic, a retinoid, and an antibacterial in a gel formulation.

The FDA approval was based on a small study, in which 38.9% of patients with relapsed or refractory disease went into complete remission.

Medtronic's Aurora extravascular implantable cardioverter-defibrillator system uses a single lead implanted substernally to allow anti-tachycardia pacing and low-energy defibrillation.

The approval provides an alternative administration option for delivering the drug to patients with moderately to severely active ulcerative colitis or Crohn's disease.

The single shot will cover the five most common serogroups that cause meningococcal disease in children and young adults.

The US health regulator has approved the expanded use of BioMarin Pharmaceutical's once-daily injection to treat children under the age of 5 with the most common form of short-limbed dwarfism.

Bimekizumab is the first IL-17A and IL-17F inhibitor approved by the FDA for adults with psoriasis.

Zilucoplan is the first once-daily, subcutaneous, self-administered, targeted C5 complement inhibitor for adults with gMG who are AChR antibody positive.

The approval allows for continuous immunotherapy treatment around surgery for resectable non-small cell lung cancer.

The new approval expands the melanoma indication for nivolumab to earlier-stage disease.

Etrasimod is the second oral sphingosine-1-phosphate (S1P) receptor approved in the US for treating moderate to severe active ulcerative colitis in adults.

The single-arm approval study reported an objective response rate of 75% among treatment-naive patients.

In a complete response letter, the FDA said the clinical meaningfulness of patisiran's effects in cardiomyopathy of ATTR amyloidosis are not established, despite good reviews from an advisory panel.

This new route of administration is expected to become available during the fourth quarter of 2023.

The drug, adalimumab-afzb (Abrilada), is the second adalimumab biosimilar approved with interchangeability status. It will be available later this month.

The FDA said on Tuesday it authorized an updated version of Novavax's COVID-19 vaccine for emergency use in individuals aged 12 years and older.

Tocilizumab-bavi (Tofidence) will offer a lower-cost option for patients with autoimmune conditions, the drug manufacturer, Biogen, stated.

Takeda expects subcutaneous vedolizumab for UC maintenance therapy to be available in the United States as a single-dose pre-filled pen (Entyvio Pen) by the end of October.

The agency approved the tyrosine kinase inhibitor for pediatric patients with chronic phase Ph+ chronic myelogenous leukemia that is newly diagnosed or resistant or intolerant to prior therapy.

The US Food and Drug Administration gave the SGLT2 inhibitor empagliflozin (Jardiance) a new indication for treating adults with isolated chronic kidney disease.

This makes ritlecitinib the first medicine authorized by the EC to treat individuals with severe alopecia areata as young as 12 years of age.

"Momelotinib is an important emerging agent for these more anemic patients," one expert said.

This is the second drug to receive a labeling update under the agency's Project Renewal program, which aims to keep labels of older cancer drugs up to date with current practice.

The transcatheter stent-like device diverts arterial flow to the lower-extremity venous system to treat 'no-option' patients with chronic limb-threatening ischemia.

The GENESIS trial reported substantially better stem cell mobilization when patients with multiple myeloma received motixafortide alongside filgrastim.

The FDA today authorized the newest COVID-19 vaccine, the first not to target the initial or 'ancestral' strain of the virus.

The UK drug regulator said on Tuesday it has approved an updated COVID-19 vaccine by Pfizer and its German partner BioNTech that targets only the Omicron XBB.1.5 subvariant.

The EMA safety committee recommends new measures to limit topiramate use in young women based on recent data suggesting more neurodevelopmental disorders for offspring when it's used during pregnancy.

The app-based system can now make insulin dose recommendations based on continuous glucose monitor (CGM) data.