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FDA grants breakthrough status to Grin Therapeutics’ radiprodil
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to Grin Therapeutics’ radiprodil for ...
policymed.com13d
FDA Releases Draft Guidance on the Accelerated Approval Process
The United States Food and Drug Administration (FDA) recently released a draft guidance, Expedited Program for Serious ...
FiercePharma1d
In letter to RFK Jr., Democrats flag threats to drug review process from FDA firings
HHS secretary Robert F. Kennedy Jr. has been on the receiving end of two heated letters from lawmakers outlining the threats ...
Cure Today1d
FDA Grants Fast Track Designation to AUTX-703 In R/R AML
The Food and Drug Administration granted fast track designation to AUTX-703 for relapsed or refractory acute myelogenous ...
JD Supra13d
A Model’s Credibility Is in the Details: FDA Draft Guidance on the Use of AI Models in Drug and Biological Product Development
In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI) ...
CRISPR: From Discovery To Clinic—And Charting A Path Forward
No doubt 2025 will usher in many more advances in CRISPR therapies, thanks to the FDA’s new Platform Technology Designation ...
Aspire Biopharma Holdings, Inc., Provides an Update on Lead Product Candidate: High-Dose, Sublingual Aspirin
Initial feasibility study of its soluble, Ph neutral, fast acting granular or powder drug delivery system is complete ...
Roll Call5d
Senate Democrats press HHS over FDA firings
Jeanne Shaheen, D-N.H., the ranking Democrat on the Appropriations Committee’s subcommittee on Agriculture, Rural Development ... They underscore that the FDA’s drug, device and tobacco ...
USA Today4d
Generic Wegovy, Ozempic compounds may become harder to get as FDA removes drug from shortage list
More on semaglutide compounds:Shortage of popular drugs Wegovy and Ozempic is over, FDA says. Americans who ... For Hims and other compounders, this development starts the clock on having ...
The Hill4d
Ozempic and Wegovy officially moved off FDA’s drug shortage list
Ozempic and Wegovy, the widely popular forms of semaglutide sold to treat diabetes and obesity, have officially been removed from the Food and Drug Administration’s (FDA) drug shortage list ...