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 ...
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 ...
Amneal Pharma: FDA Approves NDA For Pyridostigmine Bromide Extended-Release Tablets
Amneal Pharmaceuticals (AMRX) announced it has received FDA approval of its New Drug Application for Pyridostigmine Bromide ...
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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.
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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 Oncology3h
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 ...