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Regeneron Announces Expanded Collaboration with HHS to Develop Antibody Treatments for New Coronavirus

TARRYTOWN, N.Y., Feb. 4, 2020 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced an expanded agreement with the U.S. Department of Health and Human Services (HHS) to develo

FDA Approves Tukysa (tucatinib) for People with Advanced Unresectable or Metastatic HER2-Positive Breast Cancer

BOTHELL, Wash.--(BUSINESS WIRE) April 17, 2020 -- Seattle Genetics, Inc. (Nasdaq:SGEN) today announced the U.S. Food and Drug Administration (FDA) granted approval to Tukysa™ (tucatinib) tablets in co

FDA Approves Pemazyre (pemigatinib) as First Targeted Treatment for Adults with Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma

WILMINGTON, Del.--(BUSINESS WIRE)--Apr. 17, 2020 -- Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Pemazyre (pemigatinib), a kinase inhibitor indica

CTI BioPharma Establishes Accelerated Approval Pathway for Pacritinib in Treating Myelofibrosis Patients With Severe Thrombocytopenia

SEATTLE, Feb. 3, 2020 /PRNewswire/ -- CTI BioPharma Corp. (Nasdaq: CTIC) today announced that following a meeting with the U.S. Food and Drug Administration ("FDA" or "the Agency")

FDA Approves Jelmyto (mitomycin gel) for Treatment of Low-Grade Upper Tract Urothelial Cancer

April 15, 2020 -- Today, the U.S. Food and Drug Administration approved Jelmyto (mitomycin gel), the first therapy to treat low-grade upper tract urothelial cancer (UTUC). Urothelial cancer is a cance

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