FDA Issues Final Guidance on Biosimilar Interchangeability
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 Approves Expanded Use of Doptelet to Treat Thrombocytopenia
FDA has approved an expanded indication for Dova Pharmaceuticals’ Doptelet (avatrombopag) to treat adults with chronic immune thrombocytopenia.
FDA Approves Pediatric Hexavalent Combination Vaccine
Sanofi and Merck’s Vaxelis has been approved by the U.S. Food and Drug Administration.
Accelerated Dosing Regimen Approved for Japanese Encephalitis Vaccine
Valneva USA has received FDA approval of an accelerated dosing regimen for IXIARO (Japanese encephalitis vaccine, inactivated, adsorbed).
Nivestym, a Biosimilar to Neupogen, Approved by FDA
Pfizer’s Nivestym (filgrastim-aafi) has been approved by FDA for all eligible indications of the reference product.
First Cancer Drug for Specific Gene Mutation Gets FDA Approval
FDA has granted accelerated approval to Keytruda (pembrolizumab) for patients whose cancers have a specific genetic feature (biomarker).
Takeda Receives FDA Approval to Manufacture Flexbumin at Georgia Facility
FDA approved Takeda Pharmaceuticals’ second submission for its new plasma manufacturing facility near Covington, Ga.
CMV Saliva Test Approved by FDA
Meridian Bioscience has received FDA clearance for its new Alethia CMVMolecular Amplification Test (formerly, the Illumigene brand).
IVIG Manufacturing Process for Bivigam Approved by FDA
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.
Novo Nordisk’s Esperoct Approved to Treat Individuals with Hemophilia A
FDA approved Esperoct (antihemophilic factor[recombinant], glycopegylatedexei), an extended half-life factor VIII molecule for replacement therapy in people with hemophilia A.
