First Foundation receives 174 applications for funding; new full-time staff hired with more to come
With the Oct. 5 deadline come and gone, the West Virginia First Foundation received a total of 174 grant applications for ...
AI Simulations Help Drug Trials
AI-based clinical simulation systems can be a game-changer for the pharmaceutical industry. The ability to predict clinical ...
MedPage Today2d
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 ...
Zealand Pharma Gets FDA Complete Response Letter for Hypoglycemia New Drug Application
Zealand Pharma said it has received a complete response letter from the Food and Drug Administration related to its new drug application for dasiglucagon for the prevention and treatment of ...
Cure Today2d
FDA Clears Application to Study Stem Cell-Based Treatment for High-Grade Glioma
CLD-101 is a novel stem cell-based treatment that delivers oncolytic viruses to tumors, which may benefit patients with newly ...
Magdalena Biosciences, a Joint Venture Between Jaguar Health and Filament Health, to Present October 16 at BIO Investor Forum
Magdalena aiming to submit Investigational New Drug (IND) application in early 2025 to the FDA for a next-generation psychoactive prescription drug candidate for potential mental health indications ...
Managed Healthcare Executive2d
FDA Accepts NDA for Menopause Drug, Elinzanetant
Bayer announced today that the FDA has accepted their new drug application (NDA) for menopause drug, elinzanetant, to treat ...
Outsourcing-pharma2d
Antag Therapeutics gets FDA clearance to start clinical trials with new obesity drug
The FDA decision will enable Antag Therapeutics to initiate the clinical development of its lead candidate drug, a ...
FierceBiotech1d
'Impossible' FDA adcomm ends in favor of Stealth’s ultra-rare disease med
Difficult. Impossible. Agonizing. Worse than voting in the national election. | Difficult. Impossible. Agonizing. Worse than ...
Kymera Therapeutics Announces FDA Clearance of Investigational New Drug Application for KT-621, a First-in-Class, Oral STAT6 Degrader
Kymera Therapeutics Announces FDA Clearance of Investigational New Drug Application for KT-621, a First-in-Class, Oral STAT6 Degrader ...
CBO evaluates the drug pricing policy menu
A slate of popular policies commonly bandied about to help reduce drug costs would each cut average prices by only a handful of percentage points, according to a recent Congressional Budget Office ...