Two pharmaceutical companies and the U.S. Food and Drug Administration faced off in D.C. federal court Friday over allegations that the federal agency wrongly approved a treatment that rivals Jazz Pharma's narcolepsy drug despite Jazz's…
On April 30, 2024, the US Federal Trade Commission (“FTC”) announced that it had sent “warning letters” to 10 branded pharmaceutical manufacturers, alleging that the companies had made “improper or inaccurate listing of patents” in the…
A pair of Democratic senators introduced new legislation to limit the levels of harmful metals in commercial baby food, they announced Thursday. The bill, called “The Baby Food Safety Act of 2024,” would give the U.S. Food and Drug…
An investigation published by The BMJ today raises concerns about financial entanglements between US Food and Drug Administration (FDA) chiefs and the drug and medical device companies they are responsible for regulating.
On March 22, 2024, the Federal Trade Commission ("FTC") filed an amicus brief in Teva Branded Pharmaceutical Products R&D, et al. v. Amneal Pharmaceuticals of New York, LLC, et al., 2:23-cv-20964, U.S. District Court for the District of…
Texas health officials last month confirmed a case of bird flu in a person. Now, the U.S. Food and Drug Administration reported that it has found evidence of the virus in commercially sold milk.
Antibody-drug conjugate (ADC) is a promising class of cancer treatments with accelerating U.S. Food and Drug Administration (FDA) approval and rapidly growing market size as discussed in previous articles in this series. This article…
The U.S. Department of Agriculture and the U.S. Food and Drug Administration recorded a total of 313 food recalls and public health alerts in 2023, according to a report by Public Interest Research Group.
The U.S. Food and Drug Administration said Tuesday that samples of pasteurized milk had tested positive for remnants of the bird flu virus that has infected dairy cows.
The U.S Food and Drug Administration has announced that fragments of the avian flu virus were found in some pasteurised milk samples in the United States. While the government insists that the milk is safe to consume, it states that it is…
The U.S. Food and Drug Administration (FDA) has approved the immunotherapy-boosting drug N-803, which is marketed under the brand name Anktiva, to be used in combination with the immunotherapy Bacillus Calmette-Guerin (BCG) for the…
The U.S. Food and Drug Administration (FDA) has announced the establishment of the “Center for Drug Evaluation (CDER) Center for Clinical Trial Innovation” (C3TI). C3TI is intended to be a “central hub” within CDER aimed at enhancing…
The Food and Drug Administration continues using import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and modifies the alerts as needed. Recent modifications to FDA’s import alerts, as…
Based on results from trials in people with sleep apnea, the company said it plans to submit the material to the US Food and Drug Administration to potentially expand the use of Zepbound for obstructive sleep apnea.
Based on results from trials in people with sleep apnea, the company said it plans to submit the material to the US Food and Drug Administration to potentially expand the use of Zepbound for obstructive sleep apnea.
The contract tasks Kaléo with developing a novel pralidoxime chloride (2-PAM) auto-injector for U.S. Food and Drug Administration (FDA) approval within 3 years, with an ultimate goal of enabling later procurement of the 2-PAM auto…
The pharmaceutical giant plans to present the trial data at an upcoming medical conference and submit them to the U.S. Food and Drug Administration mid-year.
The head of the U.S. Food and Drug Administration (FDA), Dr. Robert Califf, pushed lawmakers on Thursday to pass a bill that would mandate that food manufacturers perform testing for lead in their products that are getting imported into…