United States Food and Drug Administration
Trumps US Manufacturing Push, New Vaccine Policy, Novos Weight Loss Pill up for FDA Review
Policy, trade deficits, Vaccines, United States Food and Drug Administration
Aldeyra hopes new data for dry-eye disease drug will satisfy FDA
United States Food and Drug Administration, Aldeyra, reproxalap, Approved, Dry Eye Syndromes, Clinical Trials, New Drug Application
Trump, FDA zero in on foreign factories to give domestic sites an edge
United States Food and Drug Administration, United States, Transplant Registry Unified Management Program, foreign factories, manufacturers
PTC crashes as win for Novartis-partnered Huntington’s drug fails to convince investors
factor IX, PTC518, Accelerated, Approved, United States Food and Drug Administration
Capricor shares turn red as FDA plans deramiocel adcomm, likely the first under new commissioner
United States Food and Drug Administration, Capricor, deramiocel, Market, Review [Publication Type], Biologics License Application, first
FDA lifts clinical hold on Atara’s Epstein-Barr T-cell programme
United States Food and Drug Administration, Study on Hold, Atara, Hoist device, Atara ‘s, EBVALLO
Novo eyes fourth-quarter FDA verdict for oral Wegovy filing
Obesity, Novo, United States Food and Drug Administration, Decision, Oral cavity, Wegovy, semaglutide, Overweight
FDA delays decision date on Cytokinetics’ heart drug to year-end in unusual safety program back-and-forth
Cytokinetics, aficamten, FDA delay, PDUFA date extension, hypertrophic obstructive cardiomyopathy (oHCM), Risk Evaluation and Mitigation Strategy (REMS), regulatory setback
FDA frees Amgen’s phase 1 obesity asset from clinical trial hold
Obesity, United States Food and Drug Administration, Amgen, MariTide, Study on Hold, Participant
FDA withdraws two final guidances, pulls compliance deadlines for bone allograft makers
United States Food and Drug Administration, Allogeneic bone graft, Mycobacterium tuberculosis, guidances, Disease Outbreaks, standards characteristics