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
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