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Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.

Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.

One of the FDA’s potential approvals this month could break an existing monopoly in the treatment space for a rare growth disorder.

With immunology and inflammation blockbusters like AbbVie’s Skyrizi and Rinvoq reeling in nearly $7 billion combined in the third quarter, the pipeline-in-a-product strategy has never been more attractive.

With pricing pressures climbing, Pfizer, Eli Lilly and other major drugmakers are looking to sell their products directly to patients. Analysts are skeptical that these efforts, including those announced to much fanfare from the White House, will result in meaningful reductions in drug spending.

Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.

After a leading study caused the FDA to slap its most stringent warning on hormone replacement therapies for menopause more than two decades ago, the regulator is changing course in what FDA Commissioner Marty Makary called a “historic day for women in the United States.”

The cholesterol-lowering drug is part of a suite of medicines that also includes MariTide and that Amgen Chief Medical Officer Paul Burton hopes will make the company the “undisputed leader in the management of cardiometabolic risk for patients” by 2030.

A new generation of companies is eyeing the existing, sizeable hair loss market, hoping that better formulations and new scientific targets will finally produce treatments that are safer and more effective, as well as commercially successful.

The nausea and other gastrointestinal side effects of weight loss drugs like Novo Nordisk’s Wegovy or Eli Lilly’s Zepbound will limit how much these drugs can help patients and stunt the overall obesity market unless we approach the problem head on.