Kymriah, Vabomere, and benzidazole approvals joined by new indications for Austedo, Faslodex.
FDA has been closing out the summer with a rash of approvals, including three novel agents. Novartis AG's Kymriah, the first CAR-T cell therapy, may have dominated headlines, but FDA also approved a new antibiotic (The Medicines Co.s Vabomere) and benznidazole, the first Chagas disease therapy.
FDA also cleared the return to market of Pfizer Inc.'s Mylotarg, a hematologic oncology agent that was withdrawn in 2000, and a new first-line indication for AstraZeneca PLC's...
The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.
The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.
The FDA questioned Pfizer’s reliance on a “large, incompletely defined” subgroup of castration-resistant prostate cancer patients without known HRR gene alterations in its review of the proposed expansion of Talzenna’s first-line indication for HRR-mutated CRPC to an all-comers population.
