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A bill that would prevent pharma companies from blocking generic competition by patenting their drugs’ Risk Evaluation and Mitigation Strategy (REMS) programs is making a return appearance in the 118th Congress. Read More
In its latest annual report on drug safety priorities, the FDA’s Center for Drug Evaluation and Research (CDER) highlighted the agency’s continued focus on COVID-19 products and its commitment to safety around opioids. Read More
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