News

Fierce Pharma2h
After Hetlioz’s rejection in jet lag disorder, Vanda sues FDA for right to promote off-label use
After years of back-and-forth with the FDA over Hetlioz's potential use as a jet lag disorder treatment, Vanda ...
National Law Review4h
District Court Strikes Down FDA’s LDT Rule, Opens the Door for Challenges to FDA’s Regulation of Other “Services” as Medical Devices
On Monday, March 31, a court in the Eastern District of Texas found unlawful and vacated the Food and Drug Administration’s ...
Woman's World on MSN1d
Why Are There So Many Food Recalls Lately? Food Safety Amid Uptick
From finding metal wires in chicken to listeria outbreaks in deli meat, the U.S. Food and Drug Administration (FDA) is no ...
FDA says butter recalled in 7 states; is NJ, Pa., or Del. on the list? See here.
Over 1,700 pounds of Cabot Creamery Butter may have been contaminated with fecal bacteria. See if you bought it in NJ, ...
FDA updates health risk for recalled Lean Cuisine sold nationwide, including N.Y.
The recall affected batches of Lean Cuisine butternut squash ravioli, spinach artichoke ravioli, lemon garlic shrimp stir fry ...
MPR8d
FDA Denies Approval of Reproxalap for Dry Eye Disease
The Company expects to have topline data from 2 trials assessing the effect of reproxalap on dry eye disease symptoms available in the second quarter of 2025.
FDA updates health risk for recalled cheesecake sold at Target
The U.S. Food and Drug Administration (FDA) has updated its health risk classification for Target-brand cheesecake that was ...
FDA Reviews Kidney Disease Drug From Apellis Pharmaceuticals
Apellis' Empaveli receives FDA Priority Review for rare kidney diseases C3G and IC-MPGN. Phase 3 data show strong efficacy in ...
Verywell Health10d
A New FDA-Approved Antibiotic May Help Women With Recurring UTIs
If you deal with recurrent UTIs, a new FDA-approved antibiotic called Blujepa could offer another treatment option—especially ...
Fierce Biotech10d
Merck KGaA pays $85M to nab global rights for Abbisko's rare tumor drug after phase 3 win
With the CSF-1R inhibitor space heating up, Merck KGaA has gone all-in on pimicotinib, paying Abbisko Therapeutics $85 ...
American Hospital Association11d
FDA recalls Medtronic Aortic Root Cannulas
The Food and Drug Administration has identified a Class I recall of Medtronic Aortic Root Cannulas due to a risk of ...
Targeted Oncology11d
FDA Grants Breakthrough Therapy Designation to Darovasertib in Melanoma
A phase 3 trial plans to further assess neoadjuvant darovasertib for the potential treatment of patients with primary uveal ...