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.
FDA says GE Healthcare has determined there is no risk of elevated levels of formaldehyde from using its EVair compressor and restrictions on its use ...
