FDA Updates Articles
A revised product label for Octapharma USA’s Octaplas (pooled plasma [human] solvent/detergent treated solution for intravenous infusion) to treat critically ill pediatric patients who require replacement of multiple coagulation factors has been approved by the U.S. Food and Drug Administration (FDA).
The U.S. Food and Drug Administration (FDA) released guidelines on the studies companies need to conduct to show their biosimilar is interchangeable with a biologic.
FDA has approved an expanded indication for Dova Pharmaceuticals’ Doptelet (avatrombopag) to treat adults with chronic immune thrombocytopenia.
Sanofi and Merck’s Vaxelis has been approved by the U.S. Food and Drug Administration.
Valneva USA has received FDA approval of an accelerated dosing regimen for IXIARO (Japanese encephalitis vaccine, inactivated, adsorbed).
Pfizer’s Nivestym (filgrastim-aafi) has been approved by FDA for all eligible indications of the reference product.
FDA has granted accelerated approval to Keytruda (pembrolizumab) for patients whose cancers have a specific genetic feature (biomarker).
FDA approved Takeda Pharmaceuticals’ second submission for its new plasma manufacturing facility near Covington, Ga.
Meridian Bioscience has received FDA clearance for its new Alethia CMVMolecular Amplification Test (formerly, the Illumigene brand).
ADMA Biologics has received approval from FDA for its prior approval supplement for Bivigam, allowing the company to use its optimized IVIG manufacturing process and market Bivigam to PI patients in the U.S.
FDA approved Esperoct (antihemophilic factor[recombinant], glycopegylatedexei), an extended half-life factor VIII molecule for replacement therapy in people with hemophilia A.
FDA issuing documents that should lead to smaller clinical trials, faster approvals and quicker launches of nonopioid pain medications.