Soleno Therapeutics Announces U.S. FDA Approval of VYKATTM XR to Treat Hyperphagia in Prader-Willi Syndrome
First approved therapy to address hyperphagia in individuals with Prader-Willi syndromeManagement to host conference call and webcast today, ...
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First Prader-Willi drug to reduce hunger approved by FDA
Clearance of Vykat unlocks what analysts anticipate will be a lucrative market opportunity for Soleno Therapeutics.
Soleno Gets FDA Approval for Hyperphagia Drug
Soleno Therapeutics gained approval from the Food and Drug Administration for its hyperphagia drug. The biopharmaceutical company focused on treating patients with rare diseases said Wednesday it got ...
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Reading the Tea Leaves in FDA's AI-Enabled Device Guidelines
While recent draft guidance from the Food and Drug Administration pertaining to artificial intelligence-enable medical ...
Senate confirms Marty Makary to lead FDA
The Senate on Tuesday night confirmed Marty Makary to be the Food and Drug Administration commissioner. Makary was easily ...
Taiwan News14d
InspireMD Reports Fourth Quarter and Full Year 2024 Financial Results
Financial Results for the Fourth Quarter Ended December 31, 2024 For the fourth quarter of 2024, total revenue increased by $188,000, or 10.7%, to $1,949,000, from $1,761,000 during the fourth quarter ...
CNN16d
RFK Jr. wants to eliminate FDA’s controversial food additive program. Here’s why that matters
Nearly 99% of new chemicals used in food or food packaging since 2000 were green-lit for use not by the FDA but by the food ... the cost to consumers in the form of higher prices, Califf said.
Reuters17d
Kennedy asks FDA to revise 'self-affirm' rule for food ingredient safety
This would increase transparency for consumers as well as the FDA's oversight of food ingredients considered to be safe, Kennedy said. Sign up here. "For far too long, ingredient manufacturers and ...
Philippine Daily Inquirer17d
UAAP: UST star Josh Ybañez returns but still far from top form
MANILA, Philippines — After missing four games due to an ankle injury, two-time MVP Josh Ybañez made a brief return for University of Santo Tomas in a loss to Ateneo in the UAAP Season 87 men ...
Business Standard18d
Alembic Pharma's Vadodara facility gets one Form 483 observation from US FDA
Post the conclusion of this scheduled inspection, the US FDA issued a Form 483 with one procedural observation the companys aforementioned unit. The company will provide comprehensive response to US ...
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US FDA ends Alembic Pharma's Vadodara unit inspection with one observation
This was a scheduled inspection. The USFDA issued a Form 483 with one procedural observation," Alembic Pharmaceuticals said in a regulatory filing. The company stated that it will submit a ...
CBS News27d
FDA cancels meeting to update next season's flu vaccines
It's an important meeting. What's the plan for flu vaccines this year," Dr. Paul Offit, a member of the FDA advisory committee and director of the Vaccine Education Center at Children's Hospital ...