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
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.
Supplemental New Drug Application being reviewed under FDA Real-Time Oncology Review (RTOR) and Project ORBIS pilot programs
Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC)
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
Amryt Granted Orphan Drug Designation by the FDA for AP103.
Novel technology developed by Cleveland Clinic researchers
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.
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
Phase 3 TETON study planned in 2021 for Tyvaso® in patients with idiopathic pulmonary fibrosis
CorVent Medical, a Coridea portfolio company focused on developing versatile, reusable, lifesaving ventilators, announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for primary critical care use of the company's RESPOND-19™ Ventilator.
Company eligible to receive Priority Review Voucher upon FDA approval of ACN00177
