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.
Flu Shot Does Not Cause Pregnant Women to Miscarry
A new study conducted by investigators at the Center for Clinical Epidemiology and Population Health at the Marshfield Clinic Research Institute in Wisconsin has found the flu vaccine does not cause miscarriages in pregnant women.
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).
New Gene Therapy Treatment Offers Possible Cure for SCID-X1
Researchers at St. Jude Children’s Research Hospital have cured infants with X-linked severe combined immunodeficiency (SCID-X1) using gene therapy involving a re-engineered virus.
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.
WHO Issues New Flu Vaccine Composition Recommendations for 2019-2020 Season
The WHO advisory board issued its new recommendations on the composition of the influenza vaccines for use in the 2019-20 flu season in the Northern Hemisphere.
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.
FDA Takes Steps for the Development of Non-Opioid Pain Medications
FDA issuing documents that should lead to smaller clinical trials, faster approvals and quicker launches of nonopioid pain medications.