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.
FDA has approved Grifols’ GamaSTAN to treat people exposed to measles and the hepatitis A viruses.
Although more antivaccination legislation was introduced between 2011 and 2017, bills that limited vaccine exemptions were significantly more likely to be enacted.
Subcutaneous administration of lanadelumab, an investigational monoclonal antibody intended for the prevention of attacks in patients with type I or II hereditary angioedema (HAE), significantly reduced the mean number of attacks compared to placebo treatment.
