Update on Phase III DANUBE Trial for Imfinzi and Tremelimumab in Unresectable, Stage IV Bladder Cancer
6 March 2020 -- The Phase III DANUBE trial for Imfinzi (durvalumab) and Imfinzi plus tremelimumab in unresectable, Stage IV (metastatic) bladder cancer did not meet the primary endpoints of improving
Orexo Submits Application for Vorvida® to the FDA to Enable Commercialization in the US
Uppsala, Sweden – March 6, 2020. -- Orexo AB (publ), today announces it has submitted an application to the US Food and Drug Administration (FDA) for vorvida® to enable commercialization in the US. vo
CytoDyn Treats First Patient with Leronlimab in Phase 2 Trial for GvHD under Modified Trial Protocol
VANCOUVER, Washington, March 04, 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 Upneeq (oxymetazoline hydrochloride ophthalmic solution) for Acquired Blepharoptosis (Droopy Eyelid) in Adults
BRIDGEWATER, N.J, July 09, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (Nasdaq: OSMT) (“Osmotica” or the “Company”), a fully integrated biopharmaceutical company, announced today that the U.
FDA Approves Inqovi (decitabine and cedazuridine) for Myelodysplastic Syndromes (MDS) including Chronic Myelomonocytic Leukemia (CMML)
Pleasanton, CA, Princeton, NJ, and Tokyo, Japan, July 7, 2020. -- Astex Pharmaceuticals, Inc.; Taiho Oncology, Inc.; and Otsuka Pharmaceutical Co., Ltd. today announce that the U.S. Food and Drug Admi
FDA Approves Byfavo (remimazolam injection) for the Induction and Maintenance of Procedural Sedation
Dublin, Ireland – 2 July 2020 -- Cosmo Pharmaceuticals announced today that the US Food and Drug Administration (FDA) has approved Byfavo (remimazolam injection) for the induction and maintenance of p
FDA Approves Rukobia (fostemsavir) for HIV in Adults with Few Treatment Options Available
July 2, 2020 -- ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administratio
FDA Approves Dojolvi (triheptanoin) for the Treatment of Long-Chain Fatty Acid Oxidation Disorders
NOVATO, Calif., June 30, 2020 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for rare
Scientists from Merck and the Walter and Eliza Hall Institute of Medical Research Discover Novel Class of Candidate Anti Malaria Agents that Block Multiple Stages of the Lifecycle of the Parasite
KENILWORTH, N.J. & MELBOURNE, Australia--(BUSINESS WIRE) March 4, 2020 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, and the Walter and Eliza Hall Institute of Medical R
FDA Approves Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) for HER2-Positive Breast Cancer Print this page
South San Francisco, CA -- June 29, 2020 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Phesgo, a
FDA Approves Fintepla (fenfluramine) for the Treatment of Seizures Associated with Dravet Syndrome
EMERYVILLE, Calif., June 25, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that the U.S. Food and Drug Admin
FDA Approves Mycapssa (octreotide) Oral Somatostatin Analog for Acromegaly
NEEDHAM, Mass., June 26, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ: CHMA), a commercial stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) approved
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