CBER faces mounting scrutiny after its top official, director Vinay Prasad, refused the review of Modernas flu vaccine application a move that some sa...
FDA releases the form FDA-483 with 11 observations from an inspection at Indias Eugia Pharma Specialties sterile drug manufacturing facility.
FDA awards Krystal Biotech a Regenerative Medicine Advanced Therapy designation for KB707, an inhalable gene therapy being investigated for treating l...
FDA approves Mercks Keytruda (pembrolizumab), as well as the fixed-dose combination pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex), in ...
FDA cites AGC Biologics for deficiencies in laboratory data controls and inventory management at its Bothell, WA, drug substance manufacturing site.
FDA accepts for review a Biofrontera supplemental NDA seeking to expand the label of its photodynamic therapy drug Ameluz (aminolevulinic acid hydroch...
FDA posts a draft guidance entitled Certification Process for Designated Medical Gases.
The CDER Office of Prescription Drug Promotion cautions Janssen Biotech about a direct-to-consumer TV ad for Tremfya that misleadingly overstates the ...
