FDA
The Institute for Clinical and Economic Review has again flagged “substantial concerns” with Lykos Therapeutics’ data for its MDMA-based therapy for post-traumatic stress disorder and propensity for bias.
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New FDA expert panels, such as recent meetings on SSRI use during pregnancy and on hormone replacement therapy during menopause, are drawing criticism for being one-sided. One leader says such panels are designed to reach a specific conclusion.
Amid an unprecedented turnover in leadership at the FDA and mass layoffs of staff, communication has crumbled and uncertainty runs rampant, leaving small and medium biopharma companies without a clear path forward for their therapies.
Aside from the rare disease market, Novo Nordisk also scored a key regulatory win last month for its blockbuster GLP-1 drug Wegovy, which can now be used to treat patients with metabolic dysfunction-associated steatohepatitis.
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J&J’s Janssen Pharmaceutical got the FDA’s greenlight Friday for its PARP inhibitor Akeega, which is now authorized to treat BRCA-mutated metastatic castration-resistant prostate cancer.
Despite being heavily pretreated, patients on J&J’s Talvey saw a 73.6% overall response rate in a Phase II study, winning accelerated approval from the regulator.
The FDA approved Sage and Biogen’s zuranolone Friday as the first oral medication for postpartum depression but declined to approve the application in major depressive disorder.
Friday, Iveric Bio scored a regulatory win for its geographic atrophy eye injection Izervay, just three months after the New Jersey biotech was bought by Astellas Pharma for $5.9 billion.
Partners Biogen and Sage Therapeutics had sought approval for the therapy in both postpartum depression and major depressive disorder, but the FDA rejected the application for the latter.
The regulator Wednesday approved expanding Lonsurf’s label for previously treated metastatic colorectal cancer, authorizing a combination regimen with Roche’s bevacizumab.
The FDA has approved Jemperli as an add-on to chemotherapy for patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient or microsatellite instability-high.
The FDA’s CBER approved nine novel therapies in the first half of 2023, with several more high-profile decisions on deck for the second half of the year.
After being rejected by an FDA advisory panel four years ago, Vanflyta is now approved across three phases of treatment for acute myeloid leukemia patients with the FLT3 gene mutation.
The U.S. regulator Monday approved the Beyfortus single-dose monoclonal antibody, developed jointly by the two companies, for the pediatric prevention of respiratory syncytial virus.