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

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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

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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

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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

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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

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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

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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

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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:

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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

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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

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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

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Study Data Show Abbott's CardioMEMSDevice Can Improve Care for More Patients with Heart Failure

ABBOTT PARK, Ill., Aug. 27, 2021 -- Abbott today announced results of the landmark GUIDE-HF clinical trial, a 1,000 patient randomized study designed to assess the benefits of the CardioMEMS HF System

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