Reuters5h
US FDA approves PTC Therapeutics' gene therapy for ultra-rare disorder
This allows them to produce the missing AADC enzyme that can help produce dopamine and treat the condition. PTC Therapeutics ...
FDA Recalls Chronic Kidney Disease Medication Over Impurity Concerns
Nearly 300,000 bottles of the drug, named Cinacalcet, were recalled and given a Class II recall risk level by the FDA.
The Baltimore Sun3h
FDA announces common over-the-counter cough and cold medicine doesn’t work
The FDA’s proposal comes more than a year after its outside advisers voted against the continued use of oral phenylephrine, ...
FDA Recalls 80,000 Pounds of Costco Butter Over Missing Milk Allergy Warning
Last month, the U.S. Food and Drug Administration (FDA) recalled almost 80,000 pounds of Costco's popular store-brand butter ...
FDA Recalls Costco Butter for a ‘Peculiar’ Reason—Here’s What to Know
Save the addition of salt, spices and other add-ins for taste, butter is a single-ingredient food. So, it may come as a ...
ClearPoint Neuro Announces FDA De Novo Marketing Authorization of SmartFlow Cannula for Direct Delivery of Gene Therapy to the Brain
Modifying Treatment for AADC Deficiency in the United States SOLANA BEACH, CA / ACCESSWIRE / November 13, 2024 / ...
STAT5h
FDA is still struggling with a lack of inspectors, but doesn’t have a plan, watchdog finds
A key reason positions haven't been filled is that they require travel that ranges from 25% to 75% of the time.
FiercePharma16h
After election, FDA's Califf lays out hopes for his Trump-appointed successor
While personally “disappointed” about the election’s outcome, current FDA Commissioner Robert Califf, M.D., has laid out the ...
FDA Commissioner Califf Candid on Trump's Impact: 'We Just Don't Know What's Going to Happen'
FDA Chief Robert Califf reflects on potential changes as Trump's re-election looms, expressing disappointment and ...
News Medical5h
The benefits and challenges of FDA Fast-Track and Accelerated Approval in drug development
The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs ...
philstar.com10h
Ex-FDA chief cleared over Tarlac pharmacy closure
The Sandiganbayan has acquitted former Food and Drug Administration chief Nela Charade Puno of graft, which stemmed from a ...
FierceBiotech12h
Adaptimmune gears up for another FDA submission after hitting goal in pivotal sarcoma study
Adaptimmune Therapeutics is prepping for another FDA submission after 42% of patients with sarcoma responded to the company's ...