Honolulu Star-Advertiser1h
Kennedy asks FDA to revise ‘self-affirm’ rule for food ingredient safety
U.S. Secretary of Health and Human Services Robert Kennedy Jr. directed the Food and Drug Administration on Monday to revise ...
RFK Jr. wants to eliminate FDA’s controversial food additive program. Here’s why that matters
It’s time to revamp the FDA’s “generally recognized as safe,” or GRAS, program that allows companies to add untested ...
MedTech Dive1d
Dexcom receives warning letter based on FDA inspections of 2 plants
The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...
Manila Standard1d
FDA goes digital with eServices Portal System
THE Food and Drug Administration (FDA) has launched an online application process for Certificate of Medical Device Notification (CMDN) for Class A ...
CNN15d
FDA delays when a final rule on what foods can be labeled as ‘healthy’ goes into effect
The US Food and Drug Administration’s new standards for foods before they can be labeled as “healthy” on their packaging will go into effect about two months later than planned, according to ...
Phys.org15d
Machine learning predicts stable drug forms to prevent efficacy loss
All of this applies to the molecules in pills, too. "Since 1985, drug manufacturers had only been aware of one polymorphic form of rotigotine—a medication prescribed for the treatment of ...
Entrada Therapeutics Announces FDA Removal of Clinical Hold on ENTR-601-44
Receives FDA authorization to initiate ELEVATE-44-102, a Phase 1b multiple ascending dose clinical study of ENTR-601-44 in adults living with ...
rheumatologyadvisor16d
FDA Approves Tablet Form of Evrysdi for Spinal Muscular Atrophy
Tablet shows same established efficacy and safety as the Evrysdi oral solution. HealthDay News — The U.S. Food and Drug Administration has approved a new drug application for a tablet version of ...
Tax Guru17d
National Savings Certificate: Taxability and Investment benefits
for this you must simply complete and return the duplicate savings certificates form to the post office which issued you the NSC which is needed to be replaced. The National Savings Certificate is a ...
Sky19d
New drug offers hope to children with rare form of epilepsy
Hundreds of children with a rare and severe form of epilepsy are hoping a new drug being rolled out on the NHS may provide a better quality of life. Fenfluramine has been recommended by the ...
Business Standard20d
Piramal Pharma declines after US FDA issues Form 483 with 6 observations to Turbhe unit
Piramal Pharma slipped 1.14% to Rs 195.40 after the US FDA issued a Form-483 with 6 observations to the company's Turbhe facility post a GMP inspection. In a regulatory filing made after market hours ...
healthday21d
FDA Approves Tablet Form of Evrysdi for Spinal Muscular Atrophy
TUESDAY, Feb. 18, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved a new drug application for a tablet version of Evrysdi (risdiplam) for people living with spinal muscular ...