FDA accepts for review a PTC Therapeutics NDA resubmission for Translarna (ataluren) and its use in treating nonsense mutation Duchenne muscular dystr...
FDA grants Prolong Pharmaceuticals a fast-track designation for PP-007 (PEGylated carboxyhemoglobin, bovine) and its use for treating acute ischemic s...
FDA accepts for review a Shanghai Henlius Biotech and Organon BLA for their biosimilar of Amgens Prolia/Xgeva (denosumab).
FDA warns Turkeys MedOffice Saglik Endustri Anonim Sirketi about CGMP violations in its manufacturing of finished drugs.
FDA releases a form FDA-483 with eight observations from an inspection at a Novo Nordisk drug substance manufacturing facility in Denmark.
FDA publishes a guidance setting an acceptable intake level for NITMA, a nitrosamine drug substance-related impurity, in products containing ritonavir...
FDA approves a Grifols BLA supplement for its plasma-protein based fibrin sealant Vistaseal for controlling surgical bleeding in pediatric patients.
Abeona Therapeutics resubmits a BLA for prademagene zamikeracel (pz-cel), a gene therapy for patients with recessive dystrophic epidermolysis bullosa.
