The FDA first approved eculizumab for use in adult patients with generalized myasthenia gravis in 2017, before expanding the ...

The FDA has approved Purified Cortrophin Gel (repository corticotropin injection USP) in a prefilled syringe presentation.

The Food and Drug Administration (FDA) has approved Arbli™, an oral suspension formulation of losartan potassium.  Arbli, an angiotensin II receptor ...

The FDA approved an expanded label for Iluvien, which is now indicated for the treatment of chronic noninfectious uveitis ...

A study shows that high-grade glioma tumor cells harboring DNA alterations in the gene PDGFRA responded to the drug avapritinib, which is already approved by the United States Food and Drug ...

ANI Pharmaceuticals (ANIP) announced that the U.S. FDA has approved an expanded label for Iluvien that includes an indication for the treatment ...

Treatments for dry eye disease, neuroendocrine tumors, chronic spontaneous urticaria, Barth syndrome, and migraine are under review.

Holdings announced that its supplemental new drug application, sNDA, of Gvoke VialDx has received U.S Food and Drug ...

Hard on the heels of the disclosure that Merck KGaA is talking to SpringWorks about a possible takeover, a new FDA approval could have sweetened the deal. Stamford, Connecticut-based SpringWorks ...

The FDA has approved Amgen and Allergan’s biosimilar of Roche’s Herceptin, just in time for the breast cancer blockbuster’s patent expiry. Herceptin’s main US patent expires this month ...

Dr. Reddy’s Laboratories RDY and partner, Alvotech ALVO, announced the FDA’s acceptance of a regulatory filing, seeking the approval of AVT03, a proposed biosimilar of Amgen’s AMGN Prolia (denosumab) ...