Hims & Hers Health appoints former FDA Global Regulatory Operations and Policy deputy commissioner Deb Autor as its first chief policy officer.
A new JAMA research letter finds that more than 380 clinical trials supported by the NIH lost funding this year affecting about 1 in 30 a...
HHS secretary Robert F. Kennedy Jr. reviews options to scale back the operational role of FDA commissioner Marty Makary, including the possibility of ...
Zymeworks reports that its HER2-targeted bispecific antibody Ziihera (zanidatamab-hrii) significantly improved outcomes for patients with HER2-positiv...
FDA posts a Form 483 that cites significant lapses in aseptic manufacturing practices at Sanofis sterile drug-product facility in Anagni, Italy.
FDA posts a final guidance entitled Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, ...
Bristol Myers Squibb (BMS) and Johnson & Johnson stop their Phase 3 Librexia ACS trial of the investigational anticoagulant milvexian after an indepen...
FDA commissioner Marty Makary and CBER director Vinay Prasad preview upcoming agency reforms during an FDA Direct podcast focused on the appointment o...
