Inversago Pharma Inc. (“the Company” or “Inversago”), the peripheral CB1 blockade company, today announced the U.S. Food and Drug Administration (FDA) granted a Rare Pediatric Disease (RPD) designation to the Company’s lead compound, INV-101, for the treatment of Prader-Willi syndrome (PWS).
Gemini Therapeutics, a clinical stage precision medicine company developing innovative treatments for genetically defined age-related macular degeneration (AMD), announced that GEM103, the Company’s investigational treatment for dry AMD, has been granted Fast Track designation by the United States Food and Drug Administration (FDA).
Impact on molecular tests remains low
Medicure Inc. ("Medicure" or the "Company") (TSXV: MPH) (OTC: MCUJF), a cardiovascular pharmaceutical company, today announced that through its Barbados subsidiary, Medicure International Inc., it intends to file an Investigational New Drug ("IND") application with the U.S. Food and Drug Administration ("FDA") pertaining to its legacy product Pyridoxal 5′-phosphate ("P5P", also referred to as "MC-1") for the treatment of seizures associated with pyridox(am)ine 5'-phosphate oxidase ("PNPO") deficiency.
Orismilast is a next generation oral PDE4-inhibitor with an improved therapeutic window compared to other PDE4-inhibitors
U.S. Phase 3 study underway to evaluate RHB-204 as a first-line, stand-alone, oral treatment for pulmonary NTM disease - a rare condition with no FDA-approved first-line therapy
Bioniz Therapeutics, Inc., ("Bioniz"), a clinical-stage biopharmaceutical company advancing a pipeline of first-in-class peptide-based multi-cytokine inhibitors for the treatment of cancer and autoimmune diseases, announced today that the U.S. Food and Drug Administration (FDA) provided positive feedback during the company's end of Phase 2 (EOP2) meeting for Bioniz's BNZ-1.
Ambrx announced that the U.S. Food and Drug Administration (FDA) granted ARX788 Fast Track Designation as monotherapy for the treatment of advanced or metastatic HER2-positive breast cancer patients who have received one or more prior anti-HER2 based regimens in the metastatic setting.
Two different mRNA vaccines have now shown remarkable effectiveness of about 95% in preventing COVID-19 disease in adults. As the first round of vaccine recipients become eligible to receive their second dose, we want to remind the public about the importance of receiving COVID-19 vaccines according to how they’ve been authorized by the FDA in order to safely receive the level of protection observed in the large randomized trials supporting their effectiveness.
Advances in scientific knowledge and drug development technology have provided an opportunity for new approaches to drug development, including the development of drugs for the treatment of rare diseases.
The agency also provided specific guidance for inclusion/exclusion criteria for patients seeking leronlimab under eIND authorization
Supplemental New Drug Application being reviewed under FDA Real-Time Oncology Review (RTOR) and Project ORBIS pilot programs
Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, announced today it has received guidance from the U.S Food & Drug Administration ("FDA") regarding the impact of COVID-19 on its Phase III clinical trial for osteoarthritis of the knee ("OAK").
Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC)
KRONOS ADVANCED TECHNOLOGIES, INC., (OTC MARKETS: KNOS) ("KNOS" or the "Company"), a revenue-generating, product development and production company that has significantly changed the way air is moved, filtered and sterilized announced today the availability of US-manufactured, advanced FDA and NIOSH approved PPE (personal protection equipment) products for distribution in the USA.
SENZA-PDN Study is Largest Prospective, Multicenter, Randomized Clinical Trial of Spinal Cord Stimulation Conducted to Date
Agency Supports Development of Complex Generic Drugs to Improve Competition and Access to More Affordable Medicines
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.
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.
Antibody test available on Simoa HD-X Analyzer® detects and quantitates IgG antibodies to SARS-CoV-2 in serum or EDTA plasma