Advocacy group Public Citizen petitions FDA to add new, class-wide pregnancy warnings to the labels of commonly prescribed serotonin reuptake inhibito...
FDA cites a direct-to-consumer television advertisement for AstraZenecas Farxiga (dapagliflozin) tablets.
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, ...
