FDA sends Alnylam Pharmaceuticals a complete response letter on a supplemental NDA for Onpattro (patisiran) for treating cardiomyopathy of transthyret...
FDA issues Biocon Biologics a complete response letter on its BLA for insulin aspart.
FDA grants ZKR Orthopedics a breakthrough device designation for its Lift implant technology, which is designed to delay or eliminate the need for kne...
Federal Register notice: FDA withdraws 11 ANDAs from Dr. Reddys Laboratories after the company requested the actions because the products are no longe...
FDA grants HistoSonics a de novo marketing authorization for the Edison System, which the company says uses focused sound energy to mechanically destr...
AstraZeneca urges FDA to provide more detailed guidance or recommendations on how early in the drug development process sponsors should start to colle...
FDA accepts for review a Sun Pharmaceutical Industries NDA for deuruxolitinib, an investigational oral selective inhibitor of Janus kinases JAK1 and J...
Federal Register notice: FDA announces the revocation of two Monkeypox-related Emergency Use Authorizations after the authorization holders requested ...
