FDA approves a Journey Medical NDA for Emrosi (minocycline hydrochloride extended release capsules, 40 mg) for treating rosacea inflammatory lesions.
A FDA advisory committee votes against recommending approval for Lexicon Pharmaceuticals' drug Zynquista (sotagliflozin) for adults with Type 1 diabet...
FDA backpedals on safety warnings it required on CAR-T cell therapies related to secondary cancers, according to CBER director Peter Marks.
Percussionaire recalls certain lots of its Phasitron 5 breathing circuits due to the unexpected presence of nickel coating on one of the circuits comp...
FDA approves the addition of mail-back envelopes to the existing opioid analgesic risk evaluation and mitigation strategy to help with safe disposals.
FDA brings on former Leavitt Partners consultant Amy Comstock Rick to serve as strategic coalitions director for the newly created Rare Disease Innova...
A recent inspection of Aarti Drugs Ltds active pharmaceutical ingredient manufacturing plant in India leads to a seven-item FDA Form-483.
Senator Marco Rubio (R-FL) urges FDA to take immediate action against two pharmaceutical companies based in Chinas Xinjiang region that allegedly use ...
