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.
FDA issues warning over recalled butter that may contain FECES
An urgent recall was issued for a popular butter this week and it has now emerged that it could contain feces.
US FDA approves syringe version of Argenx's immune disorder drug
The U.S. Food and Drug Administration has approved a prefilled syringe version of Netherlands-based Argenx SE's blockbuster ...
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 ...
To promote drug safety, FDA to replace animal testing with AI-based experiments, other methods
The U.S. Food and Drug Administration is replacing animal testing with human-relevant methods, including artificial ...
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, ...
FDA issues health alert after BUTTER sold across US is found to contain dangerous bacteria
Popular butter sold in seven states has been voluntarily recalled due to potentially containing dangerous bacteria.
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 ...