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Lenzilumab is meant to alleviate the symptoms of cytokine release syndrome, an immune system malfunction that can cause low oxygen levels in the lungs. Read More
Three members of an FDA advisory committee who reviewed Biogen’s investigational Alzheimer’s drug, aducanumab, have written an op-ed article in the Journal of the American Medical Association alleging an “unusual degree of collaboration” between the FDA and Biogen “potentially compromised the FDA’s objectivity” in conducting its review of the drug. Read More
The company said it has already shared the new findings with the FDA and plans to hold discussions with the agency aimed at lifting the clinical hold. Read More
CHMP said the drug’s benefits and risks remained positive and that including the data on the label would help doctors evaluate the drug when deciding to use. Read More
Novartis’ Kesimpta and Roche’s Evrysdi both received marketing authorizations from the European Commission (EC) Tuesday, setting the stage for new competing indications between the two companies. Read More
Merck has hit another snag as it seeks a new breast cancer indication for its blockbuster oncology drug Keytruda — a Complete Response Letter (CRL) from the FDA seeking more supporting evidence for its supplemental Biologics License Application (sBLA). Read More
Humanigen said it will seek an FDA Emergency Use Authorization for its monoclonal antibody lenzilumab “as soon as possible” based on positive results from a phase 3 clinical trial that showed the drug significantly reduced the risk of death for hospitalized COVID-19 patients. Read More
The FDA has granted approval for Bristol Myers Squibb’s and bluebird bio’s personalized immune-cell therapy Abecma (idecabtagene vicleucel; ide-cel) for multiple myeloma in adults, marking the first chimeric antigen receptor (CAR) T-cell therapy for the plasma-cell cancer. Read More
Myrbetriq was previously approved for treating overactive bladders in adults, but Myrbetriq Granules do not currently have a recommended adult dosage. Read More
GlaxoSmithKline (GSK) and Vir Biotechnology have filed for Emergency Use Authorization (EUA) for their SARS-CoV-2 monoclonal antibody ahead of schedule, having recently stopped their phase 3 trial after seeing significantly positive results. Read More