The U.S. Food and Drug Administration (FDA) has broadened the approved use of Amgen’s Repatha (evolocumab) for adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein cholesterol (LDL-C).
The US FDA has granted priority review to GSK’s new drug application for gepotidacin, a potential new oral treatment for uncomplicated urogenital gonorrhea.
AstraZeneca‘s supplemental biologics license application (sBLA) for Imfinzi (durvalumab) has been approved and given priority review in the U.S. FDA for the treatment of patients with [Read More…]
Genentech, a member of the Roche Group, announced Friday that the U.S. Food and Drug Administration (FDA) has rejected its application to expand the use of its cancer drug Columvi® (glofitamab-gxbm). The FDA issued a Complete Response Letter (CRL) for the supplemental Biologics License Application (sBLA), effectively declining to approve Columvi in combination with chemotherapy for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
The U.S. Food and Drug Administration (FDA) has given the green light to a new, prefilled syringe presentation of GSK’s highly effective shingles vaccine, Shingrix.
An application from GSK to increase the use of its very effective RSV vaccine, Arexvy, has been formally approved by the U.S. Food and Drug [Read More…]
A significant step in Alzheimer’s care: The FDA’s updated approval for the Amyvid PET scan allows for better diagnosis and patient selection for the latest amyloid-based treatments
The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) as the first and only targeted biologic treatment for adults with bullous pemphigoid, a rare and debilitating autoimmune skin disease.
Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the approval of STELARA® (ustekinumab) [Read More…]
In an important milestone for the treatment of hepatitis C, AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved a label expansion of MAVYRET® (glecaprevir/pibrentasvir), its pangenotypic, oral, direct-acting antiviral (DAA) therapy. The new indication [Read More…]
