Proxy Fight The New York Times has a story about how an FDA regulator’s wife’s tragic fight against cancer opened his eyes to the need to speed up the process for drug approval: In her ...

The U.S. Senate last week confirmed former Johns Hopkins surgeon and professor Dr. Marty Makary to lead the Food and Drug ...

While the Food and Drug Administration’s (FDA) stringent approval process is essential for ensuring ... This isn’t just about shaving years off a timeline. It’s about turning a glimmer ...

Leveraging FDA Fast Track and Accelerated Approval pathways Consultants can reduce drug development timelines by leveraging ... streamlining the regulatory process. Engagement with Contract ...

Zepbound contains the same active ingredient, tirzepatide, as Mounjaro, which is also made by Lilly and is FDA-approved to ...

Pharmaceutical companies are growing increasingly concerned widespread cuts at the Food and Drug Administration could set the ...

THE Anti-Red Tape Authority (ARTA) said that it will recommend to the Food and Drug ... FDA need immediate action, as it is critical to the country’s public health system. “They say that they (the ...

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.

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.

Now, the FDA has announced a timeline ... versions of drugs -- made for individual patients using raw ingredients -- are not required to go through the FDA's rigorous approval process.