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.
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.
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.
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.
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.
FDA has approved Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive
therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura.
