GENOME & COMPANY: Receives FDA IND clearance for GEN-001, its first anti-cancer microbiome therapeutic
Asia's first company to sponsor clinical trial of combination therapy of anti-cancer microbiome and anti-PD1/anti-PD-L1 drug
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CYTOSORBENTS: U.S. FDA Grants Breakthrough Designation to CytoSorb for Removal of Ticagrelor During Cardiopulmonary Bypass in Emergent and Urgent Cardiothoracic Surgery
CytoSorbents Corporation issued the following announcement on April 20.CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat cytokine storm and deadly inflammation in critically-ill and cardiac surgery patients around the world, announced that the U.S.
FDA: Coronavirus (COVID-19) Update: FDA Authorizes First Test for Patient At-Home Sample Collection
The U.S. Food and Drug Administration authorized the first diagnostic test with a home collection option for COVID-19.
CLARITY PHARMACEUTICALS: Announces US FDA Grants 67Cu-SARTATE™ Orphan Drug Designation for Neuroblastoma
Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for 67Cu-SARTATE™, a therapy for the clinical management of neuroblastoma.
JANSSEN: U.S. FDA Approves IMBRUVICA® (ibrutinib) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia (CLL)
Patients ages 70 years or younger who were new to CLL treatment lived longer without disease progression with the IMBRUVICA®-based regimen compared to patients treated with a chemoimmunotherapy regimen
NOVARTIS: Novartis Kymriah® receives FDA Regenerative Medicine Advanced Therapy designation in follicular lymphoma
If approved, relapsed or refractory (r/r) follicular lymphoma would become the third B-cell malignancy indication for Kymriah, joining approvals in children and young adults with r/r ALL, and adults with r/r DLBCL
FDA: Approves New Therapy for Triple Negative Breast Cancer That Has Spread, Not Responded to Other Treatments
The U.S. Food and Drug Administration granted accelerated approval to Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with triple-negative breast cancer that has spread to other parts of the body.
CNS PHARMACEUTICALS: Announces Filing of FDA Orphan Drug Designation for Brain Cancer Drug Berubicin
CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, today announced it has filed an application with the U.S. Food and Drug Administration (FDA) to receive Orphan Drug Designation (ODD) for its lead product Berubicin.
AMIDEBIO: U.S. FDA grants orphan drug designation to AmideBio's glucagon analog for the treatment of congenital hyperinsulinism
AmideBio, LLC, a privately held biopharmaceutical company, announced today that the US Food and Drug Administration (FDA) Office of Orphan Products Development granted an orphan drug designation to AmideBio's glucagon analog (ABG-023) for the treatment of congenital hyperinsulinism (CHI).
ALUNG: FDA Grants ALung Emergency Use Authorization (EUA) to the Hemolung® Respiratory Assist System (RAS) for the Treatment of COVID-19
ALung Technologies, Inc. issued the following announcement on April 24.ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure, announced that the Food and Drug Administration (FDA) has granted the Company Emergency Use Authorization (EUA) designation to the Hemolung® Respiratory Assist System (RAS) for the treatment of Coronavirus Disease 2019 (COVID-19) patients.
NEUROCRINE BIOSCIENCES: Announces FDA Approval of Once-Daily ONGENTYS® (opicapone) as an Add-On Treatment for Patients with Parkinson's Disease Experiencing "Off" Episodes
ONGENTYS, the First and Only Approved Once-Daily COMT Inhibitor, Decreases "Off" Time and Increases "On" Time Without Troublesome Dyskinesia When Added to Levodopa/Carbidopa in Patients with Parkinson's Disease
CITIUS: Announces Pre-IND Submission to FDA Under the Coronavirus Treatment Acceleration Program for a Novel Stem Cell Therapy for Acute Respiratory Distress Syndrome (ARDS) in COVID-19
Innovative therapy candidate uses next generation mesenchymal stem cells (MSCs) derived from a master cell bank of induced pluripotent stem cells (iPSCs)
MERCK: FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Use at an Additional Recommended Dose of 400 mg Every Six Weeks for All Approved Adult Indications
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an additional recommended dosage of 400 mg every six weeks (Q6W) for KEYTRUDA, Merck’s anti-PD-1 therapy, across all adult indications, including monotherapy and combination therapy.
NEURAPTIVE THERAPEUTICS: Announces FDA Clearance of IND Application for NTX-001, a Novel Approach for the Treatment of Patients with Peripheral Nerve Injuries
NTX-001 is a potentially transformative adjunctive treatment for peripheral nerve injuries, using a propriety system for the reconnection of severed nerves
AACC: Lab Experts Can Fill Gaps in FDA Regulation by Validating COVID-19 Antibody Tests
A new paper in AACC's Clinical Chemistry journal outlines recommendations for labs
BAUSCH HEALTH: FDA Approves Ortho Dermatologics' Labeling For JUBLIA® (efinaconazole) Topical Solution, 10%, In Patients As Young As Six Years Old
Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for JUBLIA® (efinaconazole) topical solution, 10%, a treatment for onychomycosis, a fungal infection of the toenails, which extends the age range included in the product's label to children six years of age and older.
FDA: Grants Marketing of New Device for Continuous Dialysis Therapy for use in Pediatric Patients with Certain Kidney Conditions
The U.S. Food and Drug Administration granted marketing authorization for a new device indicated to provide continuous hemodialysis or hemofiltration therapy to critically ill pediatric patients weighing between 2.5 and 10 kilograms (or 5.5 to 22 pounds).
GSK: FDA approves Zejula (niraparib) as the only once-daily PARP inhibitor in first-line monotherapy maintenance treatment for women with platinum-responsive advanced ovarian cancer regardless of biomarker status
GlaxoSmithKline plc issued the following announcement on April 29.GlaxoSmithKline plc (LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA) approved the company's supplemental New Drug Application (sNDA) for Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as a monotherapy maintenance treatment for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker status.