The FDA has denied IceCure Medical Ltd's (NASDAQ: ICCM) De Novo Classification request for the ProSense System for breast cancer, which was submitted based on interim
The FDA issued a Complete Response Letter regarding ARS Pharmaceuticals Inc's (NASDAQ: SPRY) New Drug Application (NDA) for neffy (epinephrine nasal spray) in the treatment of Allergic Reactions (Type I), including anaphylaxis (fatal allergic reaction) for
Pre-IND submission to FDA targeted for first quarter 2024Silo partners with Kymanox for SPC-15ENGLEWOOD CLIFFS, NJ, Sept. 20, 2023 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (NASDAQ:SILO) ("the Company"), a developmental
Monday, Safety Shot Inc (NASDAQ: SHOT) announced its intention to develop its Safety Shot functional beverage platform in a concentrated form to treat alcohol poisoning in hospital
60 Degrees Pharmaceuticals Inc's (NASDAQ: SXTP) subsidiary, 60P Australia Pty Ltd, has withdrawn its investigational new drug (IND) application for ACLR8-LR, a Phase 2B study of the use of tafenoquine
Clinical-stage biopharma company Reunion Neuroscience has received the FDA’s clearance on its Investigational New Drug (IND) application to begin a Phase 2 study of RE104, a novel serotonergic psychedelic compound aimed at treating postpartum depression (PPD.)
Promising exarafenib combination data in NRAS mutant melanoma; intend to select two doses in the fourth quarter of 2023 for further developmentPlan to file KIN-8741 c-MET inhibitor Investigational New Drug application
— U.S. FDA revises Boxed Warning to clarify that NUPLAZID can be used to treat patients with Parkinson's disease-related hallucinations and delusions who also have dementiaSAN DIEGO — September 18, 2023 – Acadia