News

Fierce Pharma4h
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 Review6h
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 ...
Optometry Advisor7h
FDA to Review Resubmitted BLA for Ophthalmic Bevacizumab for Wet AMD
The FDA has accepted for review a resubmission of the BLA for bevacizumab-vikg (ONS-5010) for the treatment of wet AMD.
STAT8h
RFK Jr. has yet another theory about vaccines
In today's Morning Rounds newsletter, RFK Jr.'s latest theory about vaccines, how sweeping FDA layoffs could impact drug ...
FDA says it will phase out animal testing requirement for monoclonal antibodies and drugs
The US Food and Drug Administration announced Thursday that it will be phasing out a requirement that monoclonal antibodies ...
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 ...
Pharmaceutical Technology on MSN1d
FDA approves injectable antibiotics for B Braun drug delivery system
The US Food and Drug Administration (FDA) has approved the injectable antibiotics Piperacillin and Tazobactam for use in B ...
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, ...
MPR4d
Qfitlia, a Novel Treatment for Hemophilia A or B, Gets FDA Approval
Fitusiran is a small interference RNA therapeutic designed to prevent bleeds in patients with hemophilia A or B by lowering antithrombin.
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 ...
People14d
FDA Issues Recall for Coffee Grounds in 15 States
On Tuesday, March 25, the Food and Drug Administration (FDA) issued a Class II recall on Massimo Zanetti Beverage USA. The parent company provides coffee products to retailers, one of which is Our ...