Tag Archives: approval

Lupin Announces FDA Approval of Supplemental New Drug Application for Solosec (secnidazole) for the Treatment of Trichomoniasis

BALTIMORE, July 1, 2021 /PRNewswire/ –Lupin Pharmaceuticals, Inc., the U.S. based wholly-owned subsidiary of global pharma major Lupin Limited (Lupin), announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental New Drug Application (sNDA) to expand the use of Solosec (secnidazole) to include the treatment of trichomoniasis in adults. Trichomoniasis… Read More »

Vertex Announces U.S. FDA Approval for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in Children With Cystic Fibrosis Ages 6 through 11 With Certain Mutations

BOSTON–(BUSINESS WIRE)–Jun. 9, 2021– Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved expanded use of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include children with cystic fibrosis (CF) ages 6 through 11 years who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a… Read More »

FDA OK’s Biogen’s Alzheimer’s drug: What is Accelerated Approval?

The Food and Drug Administration on Monday approved Biogen’s Alzheimer’s drug albeit to mixed reviews. In announcing its decision, the agency noted that the drug was granted “Accelerated Approval,” which allows for drugs targeted at serious conditions that fill an unmet medical need to be approved “based on a surrogate endpoint.”  Part of the controversy… Read More »

BridgeBio keeps FDA approval spree rolling, this time with nod for targeted bile duct cancer med

BridgeBio is keeping the momentum going in 2021. After winning a nod for its rare disease med Nulibry earlier this year, the FDA has handed the company an approval for its targeted cancer treatment.  The FDA blessed BridgeBio’s Truseltiq, previously known as infigratinib, with an accelerated approval in previously-treated, locally advanced or metastatic bile duct… Read More »

Chiesi Global Rare Diseases Announces FDA Approval of Ferriprox (deferiprone) for Treatment of Transfusional Iron Overload due to Sickle Cell Disease

May 1, 2021 Approval is based on demonstrated reduction in liver iron concentration Expanded indications for patients with sickle cell disease or other anemias, as well as thalassemia – BOSTON, May 1, 2021 /PRNewswire/ — Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), announced today… Read More »