FDA issues Aurolife an 11-item Form FDA-483 following a 3/24-4/10 inspection at its Durham, NC manufacturing facility that cited significant GMP defic...
Public Citizen petitions FDA to contraindicate the use of Provigil (modafinil) and Nuvigil (armodafinil) during pregnancy because they are allegedly l...
AstraZeneca and Handa Pharmaceuticals agree to pay $51.4 million to resolve allegations they participated in a pay-for-delay scheme to block generic S...
FDA grants BiVACOR a breakthrough device designation for its titanium Total Artificial Heart.
Critics call out HHS secretary Robert F. Kennedy Jr.s recent Make America Healthy Again report for citing allegedly nonexistent scientific studies.
FDA issues Stealth BioTherapeutics a complete response letter that proposes the company resubmit its elamipretide NDA to seek accelerated approval for...
FDA approves an Alcon NDA for Tryptyr (acoltremon ophthalmic solution) 0.003% for treating the signs and symptoms of dry eye disease.
HHS terminates a late-stage grant award to Moderna for developing a vaccine candidate targeting the H5 bird flu.
