Browsing Tag
United States Food and Drug Administration
193 posts
Weekly RM-718 shows double-digit BMI reduction in small hypothalamic obesity trial
Rhythm Pharmaceuticals reports an 11.6% BMI reduction with weekly RM-718 as it expands a rare obesity franchise built around three treatments.
Could monthly treatment replace burdensome peanut allergy dosing? Aravax may soon have an answer
Aravax gains FDA Fast Track status for PVX108 as Phase 2 peanut allergy data approach and preparations for a possible Phase 3 program advance.
Control Bionics (ASX: CBL) registers NeuroStrip with US FDA as commercial execution becomes the next test
Control Bionics has completed United States Food and Drug Administration establishment registration and device listing for NeuroStrip, strengthening its access to the company’s largest market while shifting investor attention toward paid adoption, subscription revenue and commercial scale.
Hopstem’s off-the-shelf neural cell therapy now targets three major brain injury markets
Two FDA clearances expand Hopstem’s hNPC01 into a three-indication neural cell platform spanning stroke and traumatic brain injury.
Deramiocel’s 9 to 3 FDA panel defeat wipes out half of Capricor’s value before August decision
Capricor loses half its value after a 9 to 3 FDA vote puts deramiocel approval, an $80 million milestone and its launch strategy at risk.
Ocugen pairs OCU410 regulatory progress with a $130m balance-sheet reset
OCU410 gains FDA RMAT status as Ocugen prepares a 300-patient Phase 3 trial and funds development with convertible debt.
Dyne’s FORCE RNA therapy reversed muscle damage in mice, and its first FSHD trial is now cleared
DYNE-302 enters clinical development after FDA clearance as Dyne expands its FORCE pipeline following a $431.4 million equity raise.
Altimmune’s $535m balance sheet backs new pemvidutide alcohol use disorder pathway
Pemvidutide reduced heavy drinking in Phase 2, opening a new market for Altimmune as investors weigh cash, dilution and Phase 3 risks.
SkinJect trial clearance gives Medicus Pharma a regulatory win as Nasdaq pressure builds
Medicus Pharma gains FDA clearance for its SkinJect Gorlin syndrome trial as stricter endpoints, secured debt and Nasdaq risks shape the outlook.
Abbott adds colorectal cancer blood test to Cologuard portfolio after Freenome FDA win
Freenome wins FDA approval for SimpleScreen CRC, triggering a $100 million Abbott payment and setting up a fall U.S. launch.