GEMTESA® is the second FDA approval for the Sumitovant Biopharma family of companies in the past weekGEMTESA® is the first new oral branded OAB medication approved by the U.S. FDA since 2012 and the first product approval for Urovant Sciences
Amryt Granted Orphan Drug Designation by the FDA for AP103.
Bracco Diagnostics Inc., the U.S subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, today announced that the U.S. Food and Drug Administration (FDA) has approved ProHance® (Gadoteridol) Injection, 279.3 mg/mL for intravenous use with magnetic resonance imaging (MRI) in pediatric patients under two years old, including term neonates, to visualize areas with disrupted blood brain barrier and/or abnormal vascularity throughout the brain, spine and associated tissues.
GEMTESA is the first new oral branded OAB medication approved by the U.S. FDA since 2012 and the first product approval for Urovant Sciences
Shenyang Tonglian Group Co., Ltd. announces FDA approval for a randomized, multicenter, placebo-controlled, double-blind clinical study of the safety and efficacy of Carrimycin for the treatment of severe COVID-19 in hospitalized patients
Novel technology developed by Cleveland Clinic researchers
Treatment leverages proprietary liposomes and first-in-class mechanism-of-action to achieve significant, sustainable pain relief
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the initiation of a rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ciltacabtagene autoleucel (cilta-cel), an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adults with relapsed and/or refractory multiple myeloma.
GT Biopharma, Inc. (OTCQB: GTBP) (GTBP.PA) an immuno-oncology company focused on innovative therapies based on the Company's proprietary NK cell engager (TriKE™) technology platform is pleased to announce the presentation of additional interim data results for the Company's lead therapeutic candidate, GTB-3550, for the treatment of high-risk myelodysplastic syndromes (HR-MDS).
The Lupus Research Alliance (LRA) congratulates GSK on the U.S. Food and Drug Administration (FDA) approval of belimumab (Benlysta®) as the first-ever treatment indicated specifically for adults with lupus nephritis (LN), a complication of systemic lupus erythematosus (SLE).
The U.S. Food and Drug Administration (FDA) has approved Benlysta to treat lupus nephritis (lupus-related kidney disease) in adults. The approval is for both the intravenous and subcutaneous formulations.
The U.S. Food and Drug Administration granted marketing authorization—under the De Novo premarket review pathway—for an anterior cruciate ligament (ACL) implant, intended to serve as an alternative to ACL reconstruction to treat ACL tears.
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IND Approval Marks Key Step in Beginning of Potentially Pivotal Trial of Berubicin
Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today filing of an Investigational New Drug (IND) application seeking permission from the Food and Drug Administration (FDA) to initiate a Phase I/II clinical trial assessing safety and signals of efficacy for treatment of Chronic Traumatic Encephalopathy (CTE) patients with JadiCells™.
Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for AYVAKIT™ (avapritinib) for the treatment of adult patients with advanced systemic mastocytosis (SM).
Agency Urges Online Marketplaces, Other Websites and Retailers to Stop Selling These Male Enhancement and Weight Loss Products to American Consumers
The U.S. Food and Drug Administration issued a new emergency use authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test which is authorized for use by patients at home with a prescription.
Test is authorized for individuals two years of age or older, including those not showing symptoms
