CNS PHARMACEUTICALS: Announces FDA Approval of IND Application for its Brain Cancer Drug Candidate Berubicin
IND Approval Marks Key Step in Beginning of Potentially Pivotal Trial of Berubicin
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GBM: Glioblastoma Multiforme Treatments Advancing as FDA Steps Up Measures Due to Rising Incidences
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FDA: Authorizes Marketing of New Implant to Repair a Torn ACL
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.
LUPUS FOUNDATION OF AMERICA: Sees Big Win with FDA Approval of Benlysta for Lupus Nephritis
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.
LRA: Pleased to Share GSK's Benlysta® (belimumab) is First Lupus Nephritis Treatment Approved by FDA
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).
GT BIOPHARMA: Announces FDA Data - GTB-3550 Trike™ Reduces Cancer Cells by 61.7% for a High-risk Myelodysplastic Syndromes (HR-MDS) Patient
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).
JANSSEN: Initiates Rolling Submission of a Biologics License Application to U.S. FDA for BCMA CAR-T Therapy Ciltacabtagene Autoleucel (cilta-cel) for the Treatment of Relapsed and/or Refractory Multiple Myeloma
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.
MOEBIUS MEDICAL: Announces FDA Clearance of IND Application for Phase IIb Clinical Trial of MM-II, a Novel Treatment for Knee Osteoarthritis Pain
Treatment leverages proprietary liposomes and first-in-class mechanism-of-action to achieve significant, sustainable pain relief
Anixa Biosciences and Cleveland Clinic Announce FDA Clearance to Initiate Clinical Trial of Breast Cancer Vaccine
Novel technology developed by Cleveland Clinic researchers
TONGLIAN GROUP: Innovative drug, Carrimycin, Receives FDA Approval for International, Multi-country Phase III Clinical Trial for the treatment of severe COVID-19 in hospitalized patients
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
UROVANT SCIENCES: Announces U.S. FDA Approval of GEMTESA® (vibegron) 75 mg Tablets for the Treatment of Patients with Overactive Bladder (OAB)
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
BRACCO DIAGNOSTICS INC.: FDA Approves Bracco Diagnostics Inc.'s ProHance® (Gadoteridol) Injection, 279.3 mg/mL, for Pediatric Patients Younger than Two Years
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.
AMRYT: Granted Orphan Drug Designation by the FDA for AP103
Amryt Granted Orphan Drug Designation by the FDA for AP103.
SUMITOVANT BIOPHARMA: Announces Urovant Sciences Receives U.S. FDA Approval of GEMTESA® (vibegron) 75 mg Tablets for the Treatment of Patients with Overactive Bladder (OAB)
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
QUANTERIX: Receives FDA Emergency Use Authorization for Semi-Quantitative Antibody Test
Antibody test available on Simoa HD-X Analyzer® detects and quantitates IgG antibodies to SARS-CoV-2 in serum or EDTA plasma
MOLECULIN: Announces Annamycin Receives FDA Orphan Drug Designation for Soft Tissue Sarcomas
Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Annamycin for treatment of soft tissue sarcomas.
EYENOVIA: Submits New Drug Application to FDA for Pharmacologic Mydriasis with MydCombi Targeting 80 Million Patient Encounters in the U.S. Annually
Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company with Phase 3 programs in presbyopia, myopia and mydriasis, today announced that it has submitted a New Drug Application (NDA) to the U. S. Food and Drug Administration (FDA) for MydCombi™, a unique fixed combination mydriatic (pupil dilation) agent. If approved, MydCombi would be the first microdosed ocular therapeutic with a high precision smart delivery system.
FDA: Approves First Generic of Drug Used to Treat Severe Hypoglycemia
Agency Supports Development of Complex Generic Drugs to Improve Competition and Access to More Affordable Medicines
NEVRO: Announces FDA Submission for HF10® Therapy in Patients with Painful Diabetic Neuropathy
SENZA-PDN Study is Largest Prospective, Multicenter, Randomized Clinical Trial of Spinal Cord Stimulation Conducted to Date