Here's How Trump's Pick To Lead The FDA Can Supercharge The Agency
The U.S. Senate last week confirmed former Johns Hopkins surgeon and professor Dr. Marty Makary to lead the Food and Drug ...
Fierce Pharma1d
FDA staff cuts could disrupt drug reviews, putting agency's critical funding programs at risk: reports
Massive cuts at the FDA have hit staff tied to drug reviews and user fees, putting future approvals in jeopardy, according to ...
Axios on MSN2d
Drug industry worries about FDA delays
Pharmaceutical companies are growing increasingly concerned widespread cuts at the Food and Drug Administration could set the ...
Compound versions of some weight loss drugs to be restricted
Zepbound contains the same active ingredient, tirzepatide, as Mounjaro, which is also made by Lilly and is FDA-approved to ...
US drug regulator delays Novavax COVID vaccine approval
The US drug regulator has missed a deadline for granting full approval to Novavax's COVID-19 vaccine, the company said ...
Fierce Biotech4d
Federal judge blocks FDA's regulation of lab-developed tests
A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses ...
Exclusive: FDA staff struggle to meet product review deadlines after DOGE layoffs
Some U.S. health regulators who review medical devices and tobacco products for safety and efficacy are struggling to meet ...
The Business Journals3d
Regenerative medicine firm Vivex Biologics navigates complex FDA approval landscape
Vivex Biologics navigates FDA regulations ... medical devices, the approval process can take six months or more. For more complex products like Vivex's, the timeline and costs escalate dramatically.
Seeking Alpha5d
Talphera outlines 2025 timeline for NEPHRO CRRT study completion and FDA approval of Niyad
CEO Vincent Angotti highlighted significant progress in the NEPHRO CRRT study, emphasizing the FDA-approved reduction ... the feasibility of the projected timeline for study completion.
Sungen Biomedical's world-first new drug SGC001 monoclonal antibody receives FDA fast track approval
US time, the world's first acute myocardial infarction (AMI) antibody drug, SGC001, developed by Sungen Biomedical—an innovative biopharmaceutical company incubated by Beijing Hotgen Biotech Co., Ltd.