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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. Read More
The FDA has said no to Cytokinetics’ new drug application (NDA) for omecamtiv mecarbil, an investigational treatment for heart failure with reduced ejection fraction (HFrEF). Read More
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 age 60 years and older. Read More
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 70 percent and expanding its program that caps patient out-of-pocket costs at $35 per month. Read More
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. Read More
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 the agency after nearly two decades. Read More
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 its blockbuster narcolepsy therapy Xyrem (oxybate). Read More
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, said FDA Commissioner Robert Califf, speaking during the agency’s Rare Diseases Day 2023 virtual public meeting on Monday. Read More