GlobalData on MSN3d
Intercept’s liver disease drug Ocaliva faces FDA approval delay
An FDA AdCom in September recommended against full approval for Ocaliva by a 13-1 vote for the treatment of primary biliary ...
Experimental ALS drug could offer new hope for patients if approved, researchers say
New hope could be on the horizon for ALS patients in the form of a “breakthrough" drug, researchers say. Neuvivo is seeking approval for an experimental medication for the neurological condition.
Curanex, botanical drug developer, files for $10M IPO
Curanex Pharmaceuticals (CURX) has filed for a proposed $10M initial public offering. According to an SEC filing, Curanex is ...
Cure Today5d
FDA Accepts New Drug Application for UGN-102 in Bladder Cancer
The FDA has accepted a new drug application for the intravesical solution of UGN-102 in low-grade intermediate-risk ...
News Medical1d
How to navigate chemistry, manufacturing, and controls (CMC ) challenges in breakthrough drug development
Learn how to effectively navigate the challenges of CMC in breakthrough drug development. Discover key strategies here.
MedPage Today13d
FDA Reviewers Cast Doubt on Drug Candidate for Barth Syndrome
In its new drug application, Stealth BioTherapeutics described elamipretide as a first-in-class mitochondrial protective ...
GlobalData on MSN3d
Avadel wins FDA approval for narcolepsy drug Lumryz in children
The expanded approval intensifies the rivalry with Jazz Pharmaceuticals, which has previously attempted to block Lumryz’s ...
How Quantum Computing Is Accelerating Drug Discovery And Development
Drug discovery has traditionally been slow and expensive, often taking decades and costing manufacturers billions. But with ...
Ozempic may help battle drug and alcohol addiction
Diet and diabetes drugs like Ozempic and Mounjaro could also help people struggling with alcohol and opioid abuse, according ...
Targeted Oncology4h
FDA Clears IND of ADRX-0405, Next-Gen ADC, in Solid Tumors
ADRX-0405 is a novel antibody-drug conjugate targeting STEAP1, and a phase 1a/b study will investigate the agent for the ...
AI Simulations Help Drug Trials
AI-based clinical simulation systems can be a game-changer for the pharmaceutical industry. The ability to predict clinical ...