FDA Updates on Drug Approvals and Safety Warnings

FDA updates on drug approvals and safety warnings highlight significant advancements in medical treatments. The FDA has approved the first generic estradiol vaginal insert for the treatment of moderate to severe dyspareunia.

Additionally, the FDA has qualified its first AI drug development tool, which will be utilized in MASH clinical trials. Recent approvals also include lisocabtagene maraleucel for relapsed or refractory marginal zone lymphoma and durvalumab for resectable gastric or gastroesophageal junction adenocarcinoma.

The FDA has granted traditional approval to daratumumab and hyaluronidase-fihj for newly diagnosed light chain amyloidosis, as well as to tarlatamab-dlle for extensive stage small cell lung cancer. Furthermore, a reformulated ranitidine has been approved following a comprehensive safety review.

The report also contains draft guidance on monoclonal antibodies and extractables and leachables. Public notifications include a warning about mR.7 SUPER 700000, which may be harmful due to hidden drug ingredients.

These updates reflect the FDA's ongoing commitment to ensuring drug safety and efficacy in the market, as detailed in the FDA News from CDER.