REPEAT — Nutriband Announces Successful Meeting Completed With United States FDA For Its Abuse Deterrent Fentanyl Patch

Nutriband met with US FDA to obtain feedback on the Chemistry, Manufacturing, and Controls plans for AVERSA™ FENTANYL (abuse deterrent ...
Green Matters on MSN

FDA Recalls More Than 140,000 Bottles of Cholesterol Medications Due to High Health Risk They Pose

Massive recall of 141,984 bottles of Cholesterol medicine gets an update. In September, the Food and Drug Administration ...
BioWorld

FDA’s CDER helmless again, amid bribery, defamation claims

The U.S. FDA once again has a leadership gap at the top of its drug center, which already has been ravaged this year by massive terminations, resignations and retirements of senior leaders. George ...
JD Supra

Shutdown Updates, FDA Orphan Drug Leader Reassigned as CMS Issues Orphan Drugs Guidance, FDA to Host Allergen Threshold Meeting, and Commissioner’s National Priority Review ...

Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), ...
FierceBiotech

After high-profile FDA exit, Peter Marks lands at Eli Lilly

Peter Marks, M.D., Ph.D., the former head of the FDA’s Center for Biologics Evaluation and Research (CBER), has joined Eli Lilly as senior vice president of molecule discovery and head of infectious ...
FiercePharma

FDA adds warning to label of J&J, Legend's Carvykti for potentially fatal intestinal disorder

The FDA has adjusted the label of Johnson & Johnson and Legend Biotech’s Carvykti, warning patients and doctors that use of the multiple myeloma treatment could increase the risk of an intestinal ...
TwinCities.com

FDA unveils drugs to receive expedited review in support of ‘national priorities’

WASHINGTON (AP) — The Food and Drug Administration on Thursday announced the first round of experimental drugs that will receive drastically expedited reviews at the agency, part of an effort to ...
Fierce Biotech

'We need to pick a lane': Lilly oncology president weighs in on FDA cancer drug policies

While most of what the FDA laid out in a recent draft guidance on the assessment of overall survival in oncology clinical ...
UPI

FDA weighs warning label change for menopause hormone therapy

The U.S. Food and Drug Administration is reviewing whether to change the warning label on hormone replacement therapy drugs used to treat menopause symptoms, a move many experts say is long overdue.
New York Post

FDA recalls 16 cinnamon brands with elevated lead levels — here’s what to know

The Food and Drug Administration is recalling 16 brands of cinnamon that contain elevated lead levels, which over time can cause neurological problems including learning disabilities in young children ...