Satellos Bioscience ($MSLE) Secures Fast Track for DMD Drug
Satellos Bioscience (NASDAQ: MSLE) has secured Fast Track designation from the U.S. Food and Drug Administration (FDA) for its drug SAT-3247, aimed at treating...
GRI Bio ($GRI) Secures FDA Orphan Drug Status for IPF Therapy
GRI Bio, Inc. (NASDAQ: GRI) has received Orphan Drug Designation from the U.S. Food and Drug Administration for its investigational therapy, GRI-0621, aimed at...
Beam Therapeutics ($BEAM) Gets FDA Nod for BEAM-304 Trial
Beam Therapeutics Inc. (Nasdaq: BEAM) has received FDA clearance for its investigational new drug application for BEAM-304, aimed at treating phenylketonuria (PKU), a rare...
FDA Approves Allergan Aesthetics’ ($ABBV) SKINVIVE for Neck Wrinkles
Allergan Aesthetics, an AbbVie company (NYSE: ABBV), has received FDA approval for SKINVIVE by JUVÉDERM® to treat neck lines in adults over 21. This...
Calidi Biotherapeutics ($CLDI) Receives FDA Pre-IND Feedback
Calidi Biotherapeutics, Inc. (NYSE: CLDI) has received crucial pre-IND feedback from the U.S. Food and Drug Administration (FDA), which provides alignment on the company's...
NovaBridge ($NBP) Gains FDA Fast Track for Givastomig
NovaBridge Biosciences (NASDAQ: NBP) has received Fast Track Designation from the U.S. Food and Drug Administration for its drug givastomig, used in combination with...
Elicio Therapeutics ($ELTX) Phase 2 Study Misses Primary Endpoint
Elicio Therapeutics, Inc. (NASDAQ: ELTX) announced results from its Phase 2 AMPLIFY-7P study, which assessed ELI-002 7P in patients with mKRAS-driven pancreatic ductal adenocarcinoma...
Cullinan Therapeutics ($CGEM) Gains FDA Orphan Drug Status for CLN-049
Cullinan Therapeutics, Inc. (NASDAQ: CGEM) has received Orphan Drug Designation from the U.S. Food and Drug Administration for its investigational drug CLN-049, aimed at...
Viatris ($VTRS) NDA for Moderate-to-Severe Acute Pain Drug Accepted by FDA
Viatris Inc. (NASDAQ: VTRS) has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for MR-107A-02, a...
Anavex Life Sciences Withdraws EU Marketing Application for Blarcamesine
Anavex Life Sciences Corp. (NASDAQ: AVXL) announced that it has withdrawn its application for marketing authorization of blarcamesine in the European Union as an...