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FDA Approves Koselugo (selumetinib) for Pediatric Patients with Neurofibromatosis Type 1 Plexiform Neurofibromas

13 April 2020 -- AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that the US Food and Drug Administration (FDA) has approv

CEPI and GSK Announce Collaboration to Strengthen the Global Effort to Develop a Vaccine for the 2019-nCoV Virus

Oslo, Norway; London, UK -- 03 February 2020 CEPI, the Coalition for Epidemic Preparedness Innovations, and GSK today announced a new collaboration aimed at helping the global effort to develop a vacc

FDA Approves Sevenfact [coagulation factor VIIa (recombinant)-jncw] for Treatment and Control of Bleeding Episodes Occurring in Adult and Adolescent Hemophilia A and B Patients with Inhibitors

LOUISVILLE, Ky., April 6, 2020 /PRNewswire/ -- HEMA Biologics, LLC, ("HEMA Biologics") today announced that the U.S. Food and Drug Administration (FDA) approved Sevenfact® [coagulation facto

CytoDyn Announces Stunning Results from Clinical Trials Evaluating mTNBC and MBC with Leronlimab and will Request an Emergency Type C Meeting with FDA to Enroll 50 Awaiting Patients with a Serious Solid Tumor Cancer Condition

VANCOUVER, Washington, Jan. 31, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 anta

Gilead Sciences Statement on the Company’s Ongoing Response to the 2019 Novel Coronavirus (2019-nCoV)

Foster City, Calif., January 31, 2020 — Gilead Sciences today issued the following statement from Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences: "Gilead is working closely with g

Pulmatrix Receives Fast Track Designation for Pulmazole for the Treatment of Asthma-ABPA

LEXINGTON, Mass., Jan. 30, 2020 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PUR1900 ("Pul

Positive Topline Results Demonstrated by Olipudase Alfa, First and Only Investigational Therapy in Late-Stage Development for Acid Sphingomyelinase Deficiency

PARIS, Jan. 30, 2020 /PRNewswire/ -- Olipudase alfa, an investigational recombinant human acid sphingomyelinase, demonstrated positive results in two separate clinical trials evaluating olipudase alfa

FDA Approves Zeposia (ozanimod) for Relapsing Forms of Multiple Sclerosis

PRINCETON, N.J.--(BUSINESS WIRE) -- Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Zeposia (ozanimod) 0.92 mg for the treatment of a

Leronlimab Under Evaluation for Potential Treatment of Coronavirus

VANCOUVER, Washington, Jan. 28, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 anta

Fulcrum Therapeutics Receives Orphan Drug Designation for Losmapimod in Facioscapulohumeral Muscular Dystrophy (FSHD) and Announces Expanded Patent Portfolio

CAMBRIDGE, Mass., Jan. 29, 2020 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically de

Incyte Announces that the TRuE-AD2 Pivotal Trial of Ruxolitinib Cream Met its Primary Endpoint in Patients with Atopic Dermatitis

WILMINGTON, Del.--(BUSINESS WIRE)--Jan. 28, 2020 -- Incyte (Nasdaq:INCY) today announced positive topline results from its randomized, vehicle-controlled, pivotal Phase 3 TRuE-AD2 study evaluating the

AstraZeneca to Recover the Global Rights to Brazikumab (MEDI2070) from Allergan

27 January 2020 -- AstraZeneca will recover the global rights to brazikumab (formerly MEDI2070), a monoclonal antibody targeting IL23, from Allergan. Brazikumab is currently in a Phase IIb/III program