News

The Manila Times6m
Ultragenyx Receives Complete Response Letter from FDA for UX111 AAV Gene Therapy to Treat Sanfilippo Syndrome Type A (MPS IIIA)
Complete Response Letter (CRL) cited specific chemistry, manufacturing and controls (CMC) related observations that are ...
Investor's Business Daily on MSN10m
Capricor Therapeutics Hammered On A Surprise FDA Rejection
Shares of Capricor TherapeuticsCAPR plummeted Friday after the Food and Drug Administration rejected its experimental ...
FOX 10 Phoenix1h
What is Bravecto Quantum? FDA approves 12-month flea and tick treatment
The Food and Drug Administration has approved a first of its kind, once-yearly shot designed to protect dogs from fleas and ...
Walmart Recalls 850,000 Water Bottles Nationwide After Reports of Blinding Injuries
The Ozark Trail 64-ounce water bottle sold at Walmart can eject its lid with dangerous force. This design flaw has caused ...
Opinion
FDA Commissioner: 100 Days of Change—Modernizing the FDA for a Healthier America | Opinion
The Food and Drug Administration (FDA) can maintain its high bar for safety and efficacy, and also cut the waste and unnecessary delays in the regulatory process.
Daily Voice2h
Deadly Defect In Infant Breathing Systems Prompts Urgent Recall, FDA Says
A major infant ventilator component has been recalled because it could come apart during use, potentially causing organ ...
Managed Healthcare Executive2h
Capricor’s DMD Cell Therapy Faces FDA Setback
The company said it was optimistic that the issues identified by the Food and Drug Administration could be resolved with new data.
Lawmakers advance $27B funding bill tackling FDA funding, hemp, farm loans
Lawmakers are making slow headway on assembling a fiscal year 2026 package of 12 annual funding bills that provide money for ...
Weighing the truth: weight management treatments in the age of social media
In a recent panel conversation, healthcare and industry experts discussed where to find reliable guidance in a sea of ...
Scripps News3h
FDA approves Moderna's COVID vaccine for children as young as 6 months old
The U.S. Food and Drug Administration approved "Spikevax," Moderna's vaccine for children aged 6 months to 11 years old. The ...
MPR4h
PSVT Treatment Etripamil Nasal Spray Gets Another FDA Review
The Food and Drug Administration (FDA) has accepted for review Milestone’s response to issues raised in a Complete Response Letter (CRL) for etripamil nasal spray (Cardamyst ™ ), an investigational ...