An FDA advisory committee unanimously agreed yesterday that GlaxoSmithKline’s investigational vaccine Arexvy (RSVPreF3-AS01E) is effective in preventing lower respiratory tract disease associated with respiratory syncytial virus (RSV) infections in people…
In the midst of swirling controversy about high insulin prices, Eli Lilly has announced that it’s reducing the cost of its most commonly prescribed — and older — insulins by…
The FDA’s Office of Generic Drugs (OGD) approved 742 abbreviated new drug applications (ANDA) in 2022 compared with 663 the previous year, according to OGD’s latest annual report. Source: Drug…
An FDA advisory committee has cleared the way for Pfizer’s investigational respiratory syncytial virus (RSV) vaccine, Abrysvo (RSVpreF) — a likely blockbuster product for Pfizer if approved. Source: Drug Industry…
Billy Dunn, director of the FDA’s Office of Neuroscience (ON) and a key figure in the FDA’s controversial June 2021 approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab), is officially leaving…
A federal appeals court has rejected Jazz Pharmaceuticals’ attempt to overturn a lower court ruling invalidating a patent claim covering the company’s Risk Evaluation and Mitigation Strategies (REMS) distribution system for…
The FDA is bringing in ethicists to help the agency better frame issues around gene editing as well as data generation using patients with rare diseases that have no cure,…
Cosmoceutical Research Center was hit with a five-observation Form 483 following an inspection of its Panorama City, Calif., facility for lack of written quality control procedures, failing to test incoming…
Attorneys general from a dozen states have filed a lawsuit against the FDA over its Risk Evaluation and Mitigation Strategies (REMS) for the abortion pill, mifepristone, arguing that the restrictions are…
A single infusion of BioMarin’s Roctavian (valoctocogene roxaparvovec) reduced bleeding rates by 84 percent for two years in patients with hemophilia A, according to a study published in The New…