FDA schedules a 10/9 Vaccines and Related Biological Products Advisory Committee meeting to make recommendations on the strain selection for influenza...
FDA approves Mercks pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for subcutaneous injection for adult and pediatric solid tumor indic...
FDA escalates medical device oversight this year, issuing more Warning Letters and relying on artificial intelligence to zero-in on compliance gaps, a...
FDA publishes a final rule rolling back a 2024 regulation that expanded the agencys authority over laboratory-developed tests.
FDA approves an AstraZeneca supplemental NDA for Airsupra (albuterol/budesonide) to expand the drugs labeling to reflect a 46% reduction of severe exa...
Regeneron says it will submit an application to FDA by the end of 2025 seeking approval for its garetosmab to treat adults with fibrodysplasia ossific...
Three Sidley attorneys suggest ways drug companies can take advantage of the flexibility in FDAs guidance on using alternative tools for facility eval...
FDA issues an alert after becoming aware that Abbott issued a letter to customers recommending updated instructions when removing the TactiFlex Ablati...
