BioSpace3d
What Trump’s Second Term Could Mean for PDUFA’s Future
Trump's pick for HHS secretary who endured confirmation hearings last week—has repeatedly criticized industry ties to the FDA ...
Charlotte’s Web Founder Aims For FDA Approval Of Autism Spectrum Disorder Drug
Joel Stanley, the founder and former CEO of Charlotte’s Web, is leading an effort to achieve approval from the FDA for a ...
FDA approves painkiller designed to eliminate the risk of addiction associated with opioids
The Food and Drug Administration approved the pill from Vertex Pharmaceuticals for acute pain that often occurs after surgery ...
With FDA approval, Genentech turns eye implant's focus to diabetes
Genentech Inc. won regulatory approval Tuesday to market an eye implant that can be refilled every six months with an already ...
JD Supra7d
FDA Publishes Its First Draft Guidance On Use of Artificial Intelligence in the Development of Drugs and Biological Products
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...
The FDA pulls key DEI initiative for cancer studies from its website
A Food and Drug Administration project to promote diversity in clinical studies of cancer treatments was removed from the ...
JD Supra16d
Drugs and Biologics at FDA: Reflections on 2024 Activity Shed Light on the Road Ahead
With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be ...
manilatimes8h
NurExone Forms Exo-Top Inc. in the U.S. for Exosome Manufacture and Commercialization
Exo-Top was established under the jurisdiction of the State of Nevada. Basing Exo-Top in the U.S. offers key advantages, including proximity to strategic partners, access to a robust biopharma ...
The Dangers Hidden In CMS’ Drug Pricing Regulation
The IRA’s price controls discourage post-marketing research. The potential benefits from expanding access to the drug to patients with other diseases will be lost.