Mark Cubans Cost-Plus Manufacturing and Compounding facility in Dallas, TX, receives a Form FDA-483 based on findings from a recent inspection.
FDA accepts for review an Ionis Pharmaceuticals NDA for donidalorsen, an RNA-targeted treatment for preventing hereditary angioedema attacks.
FDA gives the green light to Phaxiam Therapeutics for a Phase 2 study (GLORIA) to evaluate its anti-Staphylococcus aureus phages in prosthetic joint i...
FDA approves a Journey Medical NDA for Emrosi (minocycline hydrochloride extended release capsules, 40 mg) for treating rosacea inflammatory lesions.
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.
