News

FDA’s artificial intelligence is supposed to revolutionize drug approvals. It’s making up studies
Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...
BioSpace5d
FDA Opens Pilot Run of Commissioner Voucher Program
The FDA will select at most five companies that align with national priorities, including lower drug prices and increased ...
PharmExec3d
Replimune CRL Fallout: How Biopharma Leaders Should Manage a New Layer of FDA Uncertainty
A deep dive into the implications of the Replimune CRL that surprised insiders and investors, the role of new leadership at ...
BioPharma Dive6d
Former biotech executive appointed to lead FDA drug office
George Tidmarsh, a Stanford University physician who founded Horizon Pharma and later ran La Jolla Pharma, was named head of ...
Galderma's Diversified Dermatology Portfolio and Drug Pipeline Position It Well for Long-Term Growth
Galderma is a pure-play dermatology company, with a leadership position in the self-care segment of the market, with more than 90% of total sales paid by consumers out of pocket. Its long-term revenue ...
Ophthalmology Times5d
Ocugen announces appointments to retina scientific advisory board and executive leadership team
These updates support Ocugen in its efforts to pursue its goal of 3 biologics license applications (BLA) in the next 3 years.
Lassen News4d
HHS, FDA and USDA address the health risks of ultra-processed foods
Under the leadership of the U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr. and the U.S.
Pharma exec to lead FDA drug unit
The FDA has named Dr. George Tidmarsh to lead its drug division, putting him at the helm of the agency’s drug approval ...
MedPage Today on MSN1d
New FDA Drug Chief: 'Revolving Door' or Reformer?
The founder and former CEO of several pharmaceutical companies, Tidmarsh was tapped by FDA Commissioner Marty Makary, MD, MPH ...
FDA picks George Tidmarsh to head Center for Drug Evaluation and Research
The U.S. Food and Drug Administration has appointed George Francis Tidmarsh, M.D., Ph.D., as director of the Center for Drug ...
100 days into the job, FDA head talks to CNN about agency goals— and Coke’s switch to sugar
Commissioner Marty Makary says the FDA will plow ahead with big plans on ultra process foods, dietary guidelines and ...
OraSure Technologies: An Asymmetric Bet
OraSure Technologies trades near cash value with minimal debt, reflecting excessive market pessimism. Read why I rate OSUR ...