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FDA Accepts for Priority Review Biologics License Application for REGN-EB3 to Treat Ebola

TARRYTOWN, N.Y., April 16, 2020 /PRNewswire/ -- REGN-EB3 developed via same rapid response platform currently being leveraged to develop novel COVID-19 antibody therapy Regeneron Pharmaceuticals, Inc.

Mayne Pharma Submits NDA for E4/DRSP to the FDA

16 April 2020, Adelaide Australia and Liege, Belgium -- Mayne Pharma Group Limited (ASX: MYX) and Mithra Pharmaceuticals, SA (Euronext Brussels: MITRA) today announced that Mayne Pharma has submitted

First Patient Treated with Leronlimab in Phase 2b/3 Trial for COVID-19

VANCOUVER, Washington, April 15, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 ant

FDA Approves Alkindi Sprinkle (hydrocortisone oral granules) for Pediatric Adrenocortical Insufficiency

DEER PARK, Ill., Sept. 29, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rar

Roivant Doses First Patient in Pivotal BREATHE Clinical Trial Evaluating Gimsilumab in COVID-19 Patients for the Prevention and Treatment of Acute Respiratory Distress Syndrome

NEW YORK and BASEL, Switzerland, April 15, 2020 / PRNewswire -- Roivant Sciences announced today that the first patient was dosed at Temple University Hospital in Philadelphia in an adaptive, randomiz

Oragenics, Inc. Announces Early Top-Line Results of Phase 2 Clinical Trial of AG013 for Oral Mucositis in Chemoradiation Treatment of Head and Neck Cancer

TAMPA, Fla.--(BUSINESS WIRE) April 15, 2020 -- Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucos

FDA Approves Initiation of Humanigen’s Phase III Study of Lenzilumab in COVID-19 Patients

Burlingame, CA, April 15, 2020 -- Humanigen, Inc., (HGEN) (“Humanigen”), a clinical stage biopharmaceutical company focused on preventing and treating cytokine storm with lenzilumab, the company’s pro

Alnylam Receives Fast Track Designation for Vutrisiran for the Treatment of the Polyneuropathy of hATTR Amyloidosis

CAMBRIDGE, Mass.-(BUSINESS WIRE)--Apr. 14, 2020 -- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the U.S. Food and Drug Administration (FDA)

Sinovac Announces Approval of Human Clinical Trial for a Vaccine Candidate Against COVID-19

BEIJING - April 14, 2020 -- Sinovac Biotech Ltd. (NASDAQ:SVA) (“Sinovac” or the “Company”), a leading provider of biopharmaceutical products in China, today announced that the Company has obtained app

Aldeyra Announces Positive Top-Line Phase 1 Clinical Trial Results and Clinical Development Plans for ADX-629

LEXINGTON, Mass.--(BUSINESS WIRE)-Apr. 14, 2020 -- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the po

AstraZeneca Initiates CALAVI Clinical Trial with Calquence Against COVID-19

April 14, 2020 -- AstraZeneca will initiate a randomised, global clinical trial to assess the potential of Calquence (acalabrutinib) in the treatment of the exaggerated immune response (cytokine storm

Sanofi and GSK to Join Forces in Unprecedented Vaccine Collaboration to Fight COVID-19

PARIS and LONDON – April 14, 2020 -- Sanofi and GSK today announce that they have signed a letter of intent to develop an adjuvanted vaccine for COVID-19, using innovative technology from both compani