FDA accepts for priority review a Boehringer Ingelheim NDA for zongertinib (BI 1810631) for treating certain adult patients with unresectable or metas...
FDA approves a Mirum Pharmaceuticals NDA for Ctexli (chenodiol) for treating adults with cerebrotendinous xanthomatosis.
Pharmaceutical Research and Manufacturers of America says FDA should revise its recommendations for sponsors requesting meetings concerning cellular a...
In another blow to FDAs institutional knowledge, CBER deputy director Celia M. Witten leaves the agency amid a deepening staff exodus and plunging mor...
Three Arnall Golden Gregory attorneys describe steps foreign drug and medical device companies can take to prepare for what they see as a likely incre...
HHS appoints Robert Fox Foster as FDAs next chief counsel.
FDA staff tell Reuters a potentially bogus list of words that cant be used in external communications under a Trump Executive Order includes woman, di...
The Texas federal judge hearing the consolidated cases against FDA over its final rule on laboratory-developed tests promises a ruling as soon as poss...
