NDA News-CliniExpert

FDA Approves Susvimo (ranibizumab) for the Treatment of Wet Age-Related Macular Degeneration (AMD)

South San Francisco, CA -- October 22, 2021 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Susvim

FDA Approves Xipere (triamcinolone acetonide injectable suspension) for the Treatment of Macular Edema Associated with Uveitis

XIPERE™ is the First and Only Medicine to be Approved in the United States for Delivery via Suprachoroidal Injection, a Method Designed to Facilitate Targeted Delivery of Therapeutic Agents to the Ret

FDA Approves Zimhi (naloxone hydrochloride) Injection for the Treatment of Opioid Overdose

SAN DIEGO, Oct. 18, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) today announced that the U.S. Food and Drug Administration (FDA) has approved Adamis’ Zimhi™ (naloxone HC

FDA Approves Seglentis (celecoxib and tramadol hydrochloride) for the Management of Acute Pain

October 18, 2021 -- The U.S. Food and Drug Administration (FDA) approved Seglentis (celecoxib and tramadol hydrochloride), a proprietary product developed by Esteve Pharmaceuticals' R&D team.

FDA Approves Tyrvaya (varenicline solution) Nasal Spray for the Treatment of the Signs and Symptoms of Dry Eye Disease

PRINCETON, N.J., Oct. 18, 2021 /PRNewswire/ -- Oyster Point Pharma, Inc. (Nasdaq: OYST), today announced that the U.S. Food and Drug Administration (FDA) has approved Tyrvaya (varenicline solution) Na

FDA Approves Rethymic (allogeneic processed thymus tissue-agdc) One-Time Regenerative Tissue-Based Therapy for Pediatric Congenital Athymia

Rethymic is the first and only FDA-approved treatment indicated for immune reconstitution in pediatric patients with congenital athymia Children with congenital athymia are born without a thymus causi

FDA Approves Tavneos (avacopan) for the Adjunctive Treatment of ANCA-Associated Vasculitis

First FDA-approved orally-administered inhibitor of the complement 5a receptor SAN CARLOS, Calif., Oct. 08, 2021 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq: CCXI), today announced that the U.S. F

FDA Approves Livmarli (maralixibat) for the Treatment of Cholestatic Pruritus in Patients with Alagille Syndrome

FOSTER CITY, Calif.--(BUSINESS WIRE)--Sep. 29, 2021 -- Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a leader in rare liver disease, today announced that the U.S. Food and Drug Administration (FDA) has

FDA Approves Qulipta (atogepant) Oral CGRP Receptor Antagonist for the Preventive Treatment of Migraine

NORTH CHICAGO, Ill., Sept. 28, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved Qulipta (atogepant) for the preventive treatment of ep

FDA Approves Opzelura (ruxolitinib) Cream for the Treatment of Atopic Dermatitis (AD)

WILMINGTON, Del.--(BUSINESS WIRE) September 21, 2021 -- Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Opzelura™ (ruxolitinib) cream for the short-t

FDA Grants Accelerated Approval for Tivdak (tisotumab vedotin-tftv) in Previously Treated Recurrent or Metastatic Cervical Cancer

BOTHELL, Wash. & COPENHAGEN, Denmark--(BUSINESS WIRE) September 20, 2021 -- Seagen Inc. (Nasdaq: SGEN) and Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and Drug Administration (FDA

FDA Approves Byooviz (ranibizumab-nuna), a Biosimilar to Lucentis

INCHEON, Korea and CAMBRIDGE, Mass. – September 20, 2021 -- Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has approved Byoov