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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

FDA Approves Exkivity (mobocertinib) for EGFR Exon20 Insertion+ Non-Small Cell Lung Cancer (NSCLC)

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE) September 15, 2021 -- Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the U.S. Food and Drug Administrati

SK Bioscience and GSK Start Phase 3 trial of Adjuvanted COVID-19 Vaccine Candidate

Advance to Phase 3 follows positive interim Phase 1/2 immunogenicity and safety data Global clinical trial will evaluate vaccine candidate GBP510 against the AZ/Oxford COVID-19 vaccine Aim is for glob

Teva and MedinCell Announce FDA Acceptance of New Drug Application for TV-46000/mdc-IRM as a Treatment for Patients with Schizophrenia

PARSIPPANY, N.J., TEL AVIV & PARIS--(BUSINESS WIRE) August 31, 2021 -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and MedinCell (Euronext:

Bayer Starts Phase III Clinical Development Program OASIS With Investigational Product, Elinzanetant

Elinzanetant is a non-hormonal development compound investigated for the treatment of vasomotor symptoms during menopause WHIPPANY, N.J.--(BUSINESS WIRE) August 31, 2021-- Bayer, a global leader in wo

Novavax Statement on CDC Guidance Update for COVID-19 Clinical Trial Participants

GAITHERSBURG, Md., Aug. 30, 2021 -- Novavax, Inc. , a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Centers for Disease Contr

Positive Top-Line Results From Pfizer’s Phase 3 JADE DARE Trial Comparing the Efficacy of Abrocitinib and Dupilumab for Moderate to Severe Atopic Dermatitis

NEW YORK--(BUSINESS WIRE) August 30, 2021 -- Pfizer Inc. (NYSE: PFE) today announced that JADE DARE (B7451050), a 26-week, randomized, double-blind, double-dummy, active-controlled, multi-center Phase