Drugs.com - New Drug Approvals
New drug approvals news from Drugs.com. Comprehensive, up-to-date drug news for consumers and healthcare professionals.
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FDA Approves Idvynso (doravirine and islatravir) for the Treatment of HIV-1 Infection in Adults
RAHWAY, N.J.--(BUSINESS WIRE) April 21, 2026 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) approved Idvynso, a new, two-drug single-tablet regimen of... -
Cumberland Pharmaceuticals Announces Expanded Indication for Caldolor (ibuprofen) Injection
NASHVILLE, Tenn., April 16, 2026 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company, today announced it has received approval from the U.S. Food and Drug Administration (FDA) for an expanded indication... -
Travere Therapeutics Announces Full FDA Approval of Filspari (sparsentan), the First and Only Approved Medicine for Focal Segmental Glomerulosclerosis (FSGS)
SAN DIEGO--(BUSINESS WIRE) April 13, 2026 -- Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced that the U.S. Food and Drug Administration (FDA) has approved Filspari (sparsentan) to reduce proteinuria in adult and pediatric patients aged... -
U.S. FDA Grants Full Approval of Kite’s Tecartus for Adult Patients with Relapsed or Refractory Mantle Cell Lymphoma
SANTA MONICA, Calif. – April 2, 2026 – The U.S. Food and Drug Administration (FDA) has granted traditional (full) approval to Kite’s CAR T-cell therapy, Tecartus (brexucabtagene autoleucel), for adult patients with relapsed or... -
Eylea HD (aflibercept) Approved by FDA as First and Only Injectable Anti-VEGF with Dosing Intervals Up to 5 Months for Wet Age-related Macular Degeneration (wAMD) and Diabetic Macular Edema (DME)
TARRYTOWN, N.Y., April 02, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the extension of dosing intervals for Eylea HD® (aflibercept) up to... -
FDA Approves Foundayo (orforglipron), the Only GLP-1 Pill for Weight Loss That Can be Taken Any Time of Day Without Food or Water Restrictions
INDIANAPOLIS, April 1, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) approved Foundayo™ (orforglipron) for adults with obesity, or overweight with weight-related medical... -
Vertex Announces US FDA Approval for Label Extensions of Alyftrek and Trikafta, Expanding Availability of These Medicines to ~95% of All People With CF in the United States
BOSTON--(BUSINESS WIRE)--Apr. 1, 2026-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has approved expanded use of Alyftrek (vanzacaftor/tezacaftor/deutivacaftor) for the treatment of... -
FDA Approves Ponlimsi (denosumab-adet), a Biosimilar to Prolia
TEL AVIV, Israel and PARSIPPANY, N.J., March 30, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Ponlimsi...