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The FDA’s June 22 Accelerated Approval of Sarepta’s gene therapy Elevidys for Duchenne muscular dystrophy (DMD) is appropriate, despite an apparent disagreement within the department, according to CBER Director Peter Marks. Read More
Citing potential for supply disruptions to patient care, the Healthcare Distribution Alliance (HDA) has recommended a phased approach to the FDA's final implementation of the Drug Supply Chain Security Act (DSCSA) instead of meeting the hard deadline of Nov. 27. Read More
Multiple clinical trial results from two manufacturers posted in the past several days in The Lancet show high levels of success of both weight loss in obese adults and in control of type 2 diabetes through weight loss. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Read More
The U.S. government filed an appeal of a jury’s recent decision in the CDC patent infringement case involving Gilead’s HIV-prevention regimen, seeking $1 billion in compensation against Gilead’s $10 billion in revenue from the drugs. Read More
The Orphan Drug Act should give Jazz Pharmaceuticals the full seven years of exclusivity for its blockbuster narcolepsy drug, Xywav, says Jazz in its suit against the FDA, claiming the agency’s approval of a competitor drug, Lumryz, is unlawful. Read More
Over the past week, the FDA issued final guidance on oncology drug products used with certain in vitro diagnostic tests and draft guidance on formal dispute resolution and administrative hearings procedures. Read More
Addressing growing interest in the therapeutic potential of psychedelic drugs, the FDA has published a draft guidance noting multiple unique considerations for psychedelic drug development programs and challenges in designing trials. Read More
The FTC has filed an amicus brief urging a U.S. appeals court to side with the plaintiffs in a case that alleges Forest Laboratories paid several generics producers millions of dollars to drop a patent challenge for Forest’s hypertension drug Bystolic (nebivolol). Read More
PhRMA joined the constitutional showdown over the Inflation Reduction Act (IRA) by filing a complaint on Wednesday in the U.S. District Court for the Western District of Texas. Read More