FDA approves Novocures Optune Pax for use in combination with gemcitabine and nab-paclitaxel for adults with locally advanced pancreatic cancer.
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FDA posts a draft guidance entitled Certification Process for Designated Medical Gases.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 ...
A Washington Post opinion article takes issue with FDAs recent decision to reject a low-dose atropine treatment for pediatric myopia despite a large c...
