Former CDER chemistry, manufacturing and controls (CMC) reviewer Fabiola Cervantes-Gomez joins Hyman, Phelps & McNamaras as a CMC regulatory expert.
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...
Bristol Myers Squibb (BMS) and Johnson & Johnson stop their Phase 3 Librexia ACS trial of the investigational anticoagulant milvexian after an indepen...
