Lexicon Pharmaceuticals Provides Regulatory Update on Sotagliflozin in Heart Failure
The Woodlands, Texas, January 14, 2021 -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that it has received U.S. Food and Drug Administration (FDA) regulatory feedback that the results
Marinus Pharmaceuticals Receives Positive Response from FDA on Sufficiency of One Phase 3 Clinical Trial for Filing of New Drug Application (NDA) for the Use of Ganaxolone in CDKL5 Deficiency Disorder (CDD)
RADNOR, Pa.--(BUSINESS WIRE) January 13, 2021 -- Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure di
Harpoon Therapeutics Granted Orphan Drug Designation from FDA for HPN217 for Treatment of Multiple Myeloma
SOUTH SAN FRANCISCO, Calif., Jan. 13, 2021 (GLOBE NEWSWIRE) -- Harpoon Therapeutics, Inc. (NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, today anno
Novartis Ligelizumab (QGE031) Receives FDA Breakthrough Therapy Designation for Patients with Chronic Idiopathic Urticaria (CIU)
East Hanover, January 14, 2021 -- Novartis today announced that the US Food and Drug Administration (FDA) has granted ligelizumab (QGE031) Breakthrough Therapy designation for the treatment of chronic
Swissmedic Authorizes COVID-19 Vaccine Moderna for Use in Switzerland
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 12, 2021 -- Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Swissmedic, th
Vir Biotechnology and GSK announce NHS-supported AGILE study to evaluate VIR-7832 in the early treatment of COVID-19
London UK; San Francisco US 12 January 2021 -- Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) today announced an agreement with the U.K.-based AGILE initiative to evalua
U.S. FDA Accepts for Priority Review the Biologics License Application for V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine, for Use in Adults 18 Years of Age and Older
KENILWORTH, N.J.--(BUSINESS WIRE) January 12, 2021 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) accepted for pri
Regeneron Announces U.S. Government Agreement to Purchase Additional COVID-19 Antibody Cocktail Doses
TARRYTOWN, N.Y., Jan. 12, 2021 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Department of Health and Human Services (HHS) and the Department of Defense
Lilly's Donanemab Slows Clinical Decline of Alzheimer's Disease in Positive Phase 2 Trial
INDIANAPOLIS, Jan. 11, 2021 /PRNewswire/ -- Donanemab, an investigational antibody that targets a modified form of beta amyloid called N3pG, showed significant slowing of decline in a composite measur
FDA Grants Orphan Drug Designation for PVSRIPO for the Treatment of Advanced Melanoma
DURHAM, NC, January 10, 2021 -- Istari Oncology, Inc., a clinical-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for
FDA Approves Evkeeza (evinacumab-dgnb) for Patients with Homozygous Familial Hypercholesterolemia
TARRYTOWN, N.Y., Feb. 11, 2021 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) approved Evkeeza (evinacumab-dgnb) as an
FDA Approves Cosela (trilaciclib) to Decrease the Incidence of Chemotherapy-Induced Myelosuppression
RESEARCH TRIANGLE PARK, N.C., Feb. 12, 2021 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that the U.S. Food and Drug Administration (F
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