Health Ministry announces plan to simplify, speed up medicine approval process
The new framework aims to shorten the time on register new medications in Israel, making drugs more readily available to the ...
BioPharma Dive2d
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.
Healio1d
FDA recap: First new treatment for stroke in 3 decades, generic rivaroxaban and more
The FDA recently approved the first treatment in nearly 30 years for acute stroke, and the agency also approved a novel drug ...
Rolling Out1d
Your grocery store favorites face new safety scrutiny
The FDA launches sweeping changes to food safety rules that could transform grocery aisles nationwide as untested ingredients ...
What’s really in your food? RFK Jr. wants to close this FDA approval loophole
The U.S. health secretary has vowed to close an FDA loophole that has allowed food companies to self-police the safety of new ...
PharmExec1d
FDA Approves Soleno Therapeutics’ Vykat XR for Hyperphagia in Patients with Prader-Willi Syndrome
Approval of Vykat XR marks the first treatment indicated for hyperphagia in patients with Prader-Willi syndrome.
JD Supra9d
FDA Funding Changes Could Impact Biotech M&A
With companies constantly developing new therapies and technologies, the biotech industry is a hotbed of innovation. This dynamic environment ...
AFN11d
RFK Jr takes aim at self-GRAS process, but what does it mean in practice?
Proposals to eliminate the self-affirmed GRAS pathway have sent shockwaves through the food industry. But what do they mean ...