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Bristol Myers Squibb and bluebird bio Provide Regulatory Update on Idecabtagene Vicleucel (ide-cel, bb2121) for the Treatment of Patients with Multiple Myeloma

PRINCETON, N.J., & CAMBRIDGE, Mass.--(BUSINESS WIRE) May 13, 2020 -- Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced that the companies received a Refusal to

Moderna Receives FDA Fast Track Designation for mRNA Vaccine (mRNA-1273) Against Novel Coronavirus

CAMBRIDGE, Mass.--(BUSINESS WIRE) -- May 12, 2020 -- Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new gene

Relief Therapeutics Announces Filing of IND for Phase 2/3 Clinical Trial of Inhaled RLF-100 Targeting Early COVID-19 Lung Injury

Geneva. May 11, 2020 – RELIEF THERAPEUTICS Holding AG (SIX:RLF) (Relief) today announced that its U.S. partner, NeuroRx Inc., has filed an investigational protocol with the U.S. Food and Drug Administ

Acer Therapeutics to Develop Emetine as Potential COVID-19 Treatment in Collaboration with National Center for Advancing Translational Sciences, One of the National Institutes of Health

NEWTON, MA – May 11, 2020 – Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threate

FDA Approves Orladeyo (berotralstat) as the First Oral, Once-Daily Therapy to Prevent Attacks in Hereditary Angioedema Patients

RESEARCH TRIANGLE PARK, N.C., Dec. 03, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the U.S. Food and Drug Administration (FDA) has approved oral, once-d

FDA Approves Gallium 68 PSMA-11 as the First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer

December 01, 2020 -- Today, the U.S. Food and Drug Administration approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) – the first drug for positron emission tomography (PET) imaging of prostate-specific membr

RedHill Biopharma Receives FDA Approval for COVID-19 Clinical Study with Opaganib in the U.S.

TEL-AVIV, Israel and RALEIGH, NC, May 8, 2020 -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that the U.S. Food and Drug

FDA Grants Fast Track Designation For Omecamtiv Mecarbil In Heart Failure

THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif., May 8, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Cytokinetics, Incorporated (NASDAQ:CYTK) today announced that the U.S. Food and Drug Administ

U.S. FDA Clears Pluristem’s IND Application for Phase II COVID-19 Study

HAIFA, Israel, May 08, 2020 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic pro

Gilead Announces Approval of Veklury® (remdesivir) in Japan for Patients With Severe COVID-19

FOSTER CITY, Calif.--(BUSINESS WIRE) -- May 7, 2020 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted regulatory appro

Evelo Biosciences, Rutgers University, and Robert Wood Johnson University Hospital Announce Submission of IND for a Phase 2 Study of EDP1815 in COVID-19 Patients

CAMBRIDGE, Mass. and NEW BRUNSWICK, N.J., May 07, 2020 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (Nasdaq:EVLO), Rutgers University, and Robert Wood Johnson University Hospital today announced the su

Novant Health Initiates Phase 2b/3 Trial with CytoDyn’s Leronlimab for Severely and Critically Ill COVID-19 Patients

VANCOUVER, Washington and WINSTON-SALEM, N.C., May 07, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab