Tag Archives: FDA

FDA to announce crackdown on synthetic substance derived from kratom  The Washington Post Secretary Kennedy, Deputy Secretary O’Neill, Commissioner Makary, and U.S. Senator Mullin to Host Press Conference on Measures to Safeguard American Public from Dangerous Opioid 7-OH  HHS.gov Watch live: RFK Jr., health officials outline response to synthetic opioid derived from kratom  The Hill FDA recommends scheduling 7-OH as controlled substance  Investing.com FDA …

Celcuity’s breast cancer combo hits goals, teeing up FDA filing  Fierce Biotech Celcuity Stock Triples on Positive Breast Cancer Treatment Study  Yahoo Finance Celcuity’s triple cancer drug combo beats AstraZeneca in halting cancer progression, shows study  Mint Celcuity posts Phase 3 win in breast cancer, setting up challenge to Novartis and Roche  Endpoints News Gedatolisib Triplet Boosts Progression-Free Survival in Breast Cancer  Curetoday Source link

Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast The Readout Loud and author of the newsletter Adam’s Biotech Scorecard. You can reach Adam on Signal at stataf.54. In a sharp reversal, the Food and Drug Administration on …

Investing.com — The U.S. Food and Drug Administration has recommended lifting the voluntary hold on Sarepta Therapeutics (NASDAQ:SRPT)’ gene therapy Elevidys for ambulatory patients with Duchenne Muscular Dystrophy (DMD). The FDA concluded that the death of an 8-year-old boy was unrelated to the gene therapy product itself, allowing ambulatory patients to once again receive the treatment. However, the voluntary hold …

By SADIE WHITELOCKS FOR DAILYMAIL.COM Published: 15:15, 28 July 2025 | Updated: 15:16, 28 July 2025 The FDA is warning Americans of ice pops that could cause a ‘life-threatening allergic reaction.’ Tropicale Foods of Ontario, California, is recalling a variety of its Helados Mexico and La Michoacana ice pops from stores across the country because they may contain undeclared milk. People …

For Immediate Release: July 28, 2025 The U.S. Food and Drug Administration is recommending the removal of the voluntary hold for ambulatory patients who may now receive Elevidys, a Sarepta Therapeutics gene therapy for Duchenne Muscular Dystrophy (DMD). The FDA’s investigation has concluded that the death of the 8-year-old boy is unrelated to the gene therapy product itself .   …

FDA considers warning about antidepressants during pregnancy  NewsNation FDA Panel Casts Doubt on Safety of SSRI Use in Pregnancy  Medscape Millions of Americans Need These Drugs. RFK Jr.’s Minions Have Them in Their Crosshairs.  Slate Magazine An unusual FDA panel on antidepressant use during pregnancy elevated skeptics of the drugs  statnews.com F.D.A. Panel Debates ‘Black Box’ Warning for Antidepressants in Pregnancy  The New York Times …

Obstetricians and psychiatrists are concerned about a recent FDA panel spreading misinformation about the potential harms of using SSRIs during pregnancy and postpartum. AYESHA RASCOE, HOST: Should pregnant women and new mothers take antidepressants? A recent Food and Drug Administration panel raised questions about the safety of these drugs. An estimated 6% to 8% of pregnant women take antidepressants known …

Two drugs already approved by the FDA for cancer treatment may hold the key to reversing Alzheimer’s disease in patients, experts say.  Researchers from the University of California, San Francisco (UCSF) believe that letrozole, a hormone-based breast cancer drug, and irinotecan, a lung and colon cancer chemotherapy medication, can help reverse brain damage caused by the incurable neurodegenerative disease.    In …

Intrusive thoughts and panic attacks plagued Tinelle Windham throughout her first three pregnancies. During her second, a doctor recommended she start taking Zoloft, a type of antidepressant called a selective serotonin reuptake inhibitor, or SSRI. But she was wary. What about side effects? What if it harmed her baby?  “I really was leery of getting it treated that way, and …