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FDA Approves Xocova (ensitrelvir), the First and Only Oral Option to Help Prevent COVID-19 Following Exposure

OSAKA, Japan, June 1, 2026 -- Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, PhD; hereinafter “Shionogi”) announced that the U.S. Food and Drug Administr

FDA Approves Zaynich (cefepime and zidebactam) for the Treatment of Complicated Urinary Tract Infections

MUMBAI & SHORT HILLS, NEW JERSEY May 30, 2026 -- Wockhardt today announced that the U.S. Food and Drug Administration (FDA) has approved Zaynich (cefepime and zidebactam), a novel intravenous anti

FDA Approves Decnupaz (pivekimab sunirine-pvzy) for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm

NORTH CHICAGO, Ill., May 27, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved Decnupaz (pivekimab sunirine-pvzy) for the treatment

FDA Grants Accelerated Approval to Hepcludex (bulevirtide-gmod) Treatment for Chronic Hepatitis Delta Virus (HDV)

FOSTER CITY, Calif. -- (BUSINESS WIRE) May 22, 2026 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Hepclu

FDA Approves Differin Epiduo Acne Gel (adapalene/benzoyl peroxide) for Nonprescription Use in the Treatment of Acne

Zug, Switzerland - May 22, 2026 -- Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Differ

FDA Approves Baxfendy (baxdrostat) as the First Aldosterone Synthase Inhibitor Treatment for Adults with Hypertension

May 18, 2026 -- AstraZeneca’s Baxfendy (baxdrostat) has been approved in the US as a first-in-class aldosterone synthase inhibitor (ASI) for the treatment of hypertension in combination with other ant

FDA Approves Immgolis (golimumab-sldi), an Interchangeable Biosimilar to Simponi

RALEIGH, N.C., May 18, 2026 /PRNewswire/ -- Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd. ("Intas Pharmaceuticals"), focused on the development of oncolo

FDA Approves Immgolis Intri (golimumab-sldi), an Interchangeable Biosimilar to Simponi Aria (golimumab)

RALEIGH, N.C., May 18, 2026 /PRNewswire/ -- Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd. ("Intas Pharmaceuticals"), focused on the development of oncolo

FDA Grants Accelerated Approval to Beqalzi (sonrotoclax) for Relapsed or Refractory Mantle Cell Lymphoma

SAN CARLOS, Calif. -- (BUSINESS WIRE) May 13, 2026 -- BeOne Medicines Ltd. (“BeOne”) (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Adm

FDA Approves Veppanu (vepdegestrant) for the Treatment of ESR1m, ER+/HER2- Advanced Breast Cancer

NEW HAVEN, Conn., May 01, 2026 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), today with its partner Pfizer Inc. (NYSE: PFE), announced that the U.S. Food and Drug Administration (FDA) has granted

FDA Approves Langlara (insulin glargine-aldy), an Interchangeable Biosimilar to Lantus

PHILADELPHIA -- May 4, 2026 -- Lannett Company, Inc., Lanexa Biologics, a wholly owned subsidiary of Lannett, and Sunshine Lake Pharma today announced that the U.S. Food and Drug Administration (FDA)

FDA Grants Accelerated Approval for Otarmeni (lunsotogene parvec-cwha) Gene Therapy for Genetic Hearing Loss

TARRYTOWN, N.Y., April 23, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Otar