FDA taps biotech industry veteran as RFK Jr.'s top drug regulator
Tidmarsh, an adjunct professor of pediatrics and neonatology at Stanford University's School of Medicine, Fpauswill lead one of the biggest and most crucial divisions of the FDA, which reviews the vast majority of new drug applications.
The Center for Drug Evaluation and Research, or CDER, regulates over-the-counter and prescription treatments, including biologic therapies and generics. The acting head of CDER, Jacqueline Corrigan-Curay, announced in June she was retiring.
Tidmarsh will step in as the FDA and its regulatory process face massive upheaval under Health and Human Services Secretary Robert F. Kennedy Jr. Kennedy has pursued deep staff cuts across HHS and, in some cases, brought in new employees who either lack relevant scientific and medical experience or share his skepticism of vaccines.
But Tidmarsh's extensive background in the industry and involvement in the development of seven now-approved drugs is likely a sigh of relief for the pharmaceutical industry. His previous comments signal that he could take a more hardline approach to regulating drugs.
In an opinion piece in April, Tidmarsh slammed regulatory decisions made by a key official pushed out of the FDA under Kennedy, Peter Marks. That includes supporting the accelerated approval of Biogen's ill-fated Alzheimer's drug, Aduhelm, and overruling FDA staff to expand approval of Sarepta Therapeutics' Duchenne muscular dystrophy treatment Elevidys.
Last week, the FDA asked Sarepta Therapeutics to halt all shipments of Elevidys after three patients died from liver failure after taking it or a similar treatment. The company later said it would not stop shipments to treat patients with the condition who can still walk, saying data show "no new or changed safety signals" within that group.
Tidmarsh will likely have a say on that controversial accelerated approval process and the FDA's approach to prescription drug advertising. He served as CEO of La Jolla Pharmaceuticals and Horizon Pharma, the latter of which he founded before Amgen bought it for $28 billion. Tidmarsh also founded Threshold Pharmaceutical, and held senior positions at other biotech companies.
"Dr. Tidmarsh is an accomplished physician-scientist and leader whose experience spans the full arc of drug development—from bench to bedside," said FDA Commissioner Dr. Marty Makary, in a statement. "His appointment to lead CDER brings exceptional scientific, regulatory, and operational expertise to the agency."
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Insider
5 hours ago
- Business Insider
Sarepta says eight-year-old death deemed unrelated to Elevidys
Sarepta (SRPT) said in a statement Friday night: 'Just before 6:00 p.m. ET today, the U.S. Food and Drug Administration issued a press release announcing an investigation into the death of an eight-year-old Duchenne muscular dystrophy patient who had received Elevidys gene therapy. The death of this patient was deemed unrelated to treatment with Elevidys…Sarepta reported this event to FDA on June 18, 2025, via the FDA's postmarketing electronic database, FAERS. At Sarepta, patient safety and well-being are always our top priority. We are committed to upholding the highest safety standards for all of our therapies, and do so in accordance with applicable law and commitment to full regulatory transparency. Elevidys is the only approved gene therapy for families and children devastated by Duchenne, a rare, progressive and ultimately fatal disease. We remain committed to working closely with the FDA to ensure that all decisions are grounded in science and the best interests of patients, considering the compelling need of these families to access disease-modifying therapy.' Elevate Your Investing Strategy:
New York Post
6 hours ago
- New York Post
Breakthrough as two FDA-approved drugs are found to reverse Alzheimer's — including restoring memory
In a stunning scientific discovery, researchers have found that a pair of drugs can not only slow down Alzheimer's disease but actually reverse it and restore memory in mice. And the best part of all? Both are already FDA-approved — albeit for cancer. Researchers first pinpointed how Alzheimer's disease scrambles gene activity in individual brain cells. 3 Researchers have found that a pair of drugs can not only slow down Alzheimer's disease but actually reverse it and restore memory in mice. Pixel-Shot – Using the Connectivity Map database of 1,300 FDA‑approved drugs, the researchers looked for medications that reverse Alzheimer's‑associated gene expression — landing on a shortlist of five, and zeroing in on two cancer drugs. In what one researcher called a 'mock clinical trial,' they then mined 1.4 million patients' medical records, finding that those who had taken letrozole or irinotecan for cancer were significantly less likely to develop Alzheimer's. When given together in an aggressive Alzheimer's mouse model, letrozole — used to treat certain types of breast cancer in postmenopausal women — and irinotecan — an anti-cancer medication used to treat colon cancer and small cell lung cancer — reversed disease‑related gene expression signatures, dissolved toxic tau protein clumps and prevented brain degeneration. Most importantly, they restored memory and learning in mice that had already developed severe symptoms. It's an exciting development for an illness that's notoriously tricky. 3 Letrozole — used to treat certain types of breast cancer in postmenopausal women — and irinotecan — an anti-cancer medication used to treat colon cancer and small cell lung cancer — reversed disease‑related gene expression signatures, dissolved toxic tau protein clumps and prevented brain degeneration. Eric Hood – 'Alzheimer's disease comes with complex changes to the brain, which has made it tough to study and treat, but our computational tools opened up the possibility of tackling the complexity directly,' Marina Sirota, the interim director of the UCSF Bakar Computational Health Sciences Institute, said in a statement. 'We're excited that our computational approach led us to a potential combination therapy for Alzheimer's based on existing FDA-approved medications.' 'Alzheimer's is likely the result of numerous alterations in many genes and proteins that, together, disrupt brain health,' said Yadong Huang, a professor of neurology and pathology at UCSF. 'This makes it very challenging for drug development — which traditionally produces one drug for a single gene or protein that drives disease.' 3 'Alzheimer's is likely the result of numerous alterations in many genes and proteins that, together, disrupt brain health,' said Yadong Huang, a professor of neurology and pathology at UCSF. yurakrasil – The findings were published in the journal Cell. Both drugs are already FDA‑approved for other uses, which could dramatically speed up the path to human trials. However, because they are cancer drugs, repurposing them may be complex and risky. This finding adds to a growing number of potential Alzheimer's treatments. A compound found in rosemary and sage — carnosic acid — has been shown to reverse memory loss and reduce brain inflammation in mice with Alzheimer's, bringing their cognitive function back to near-normal levels. A study from Stanford Medicine found that seniors who received the shingles vaccine were 20% less likely to develop dementia over seven years. And researchers at Penn State and Stanford University discovered that a certain cancer drug could restore memory and brain function in early stage Alzheimer's models.
New York Post
6 hours ago
- New York Post
First-of-its-kind Alzheimer's center opens on Long Island: ‘Whole new world'
A first-of-its-kind day facility for Alzheimer's patients that also specifically helps their families has opened on Long Island. Amityville's new Barbara Rabinowitz Education & Resource Center includes even a special transit-focused room to teach families how to travel with their affected loved ones — using items such as real LIRR train seats and an airplane row. 8 A first-of-its-kind day facility for Alzheimer's patients that also specifically helps their families has opened on Long Island. Advertisement 8 The site is designed for professionals to aid the families of the estimated 60,000 Long Islanders battling dementia on how to better manage their circumstances. 'I'd never even imagined something like this — it would have just made life easier,' said Barbara's son Michael Rabinowitz, who worked with the Alzheimer's Foundation of America to open the 11,500-square-foot location named after his mom. 'Something like this will just teach you how to live with it. It's a whole new world for you,' the Oyster Bay man told The Post. Advertisement The site is designed for professionals to aid the families of the estimated 60,000 Long Islanders battling dementia on how to better manage their circumstances, as well as create a more calm environment for the patients themselves. The center also conducts regular memory screenings. 8 Newspaper article about Barbara Rabinowitz and the opening of the AFA Barbara Rabinowitz Education and Resource Center. Initial programming for patients focuses on enjoyable ways for them to spend their time, such as poetry in motion, karaoke, 'mind games' including true or false questions, sensory-themed bingo and a special 'Wheel of Fortune' themed word game coming Friday. 8 The center also conducts regular memory screenings. Advertisement 8 Initial programming for patients focuses on enjoyable ways for them to spend their time, such as poetry in motion, and karaoke. Helping families who need it most Rabinowitz, a recently retired 67-year-old investment banker, lost his 89-year-old mother in 2022 after she fought Alzheimer's for six years. 'We didn't even know how to approach it,' Rabinowitz said of the disease. 'The family suffers the most. … It's a real struggle, and people who haven't gone through it really wouldn't know. It's hard to explain.' He and his family launched the Rabinowitz Charitable Foundation in 2003 and have contributed to causes such as children with special needs and multiple sclerosis, which Rabinowitz's father suffered from, before turning to Alzheimer's issues. Advertisement Rabinowitz reached out to a close friend to bring the facility to LI — former local state Sen. Chuck Fuschilio, who has been the AFA's president and CEO since retiring from politics just over 10 years ago. 8 He and his family launched the Rabinowitz Charitable Foundation in 2003 and have contributed to causes such as children with special needs and multiple sclerosis. 8 Rabinowitz reached out to a close friend to bring the facility to LI — former local state Sen. Chuck Fuschilio. Fuschilio began scouring the South Shore for an appropriate location for the site, with the search leading him to a property across from and owned by Dominican Village, home to the world's oldest nun and other members of the Catholic order. 'There was a higher calling, so we all won,' he said with a smile. 'This center will fill a significant need for so many families, and we're very proud of that.' Rabinowitz is most impressed by 'not so much the science, but the psychology' that went into the facility's planning, as it also includes several sensory rooms to help handle dementia in a relaxing manner. 8 Rabinowitz is most impressed by 'not so much the science, but the psychology' that went into the facility's planning. He was happy to lead the charge on getting the property set to go, as labors of love run in the family. Advertisement The son described Brooklynite Barbara — who cared not only for her own mother but also for her husband — as the one who taught him why it's essential to do good for others in life. 'There was a lot of pressure on her, coming from very humble beginnings. They had very little, but they were great parents. They gave us what they had,' he said. 'They would be unbelievably proud of this.'
