Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...

Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...

The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.

Federal officials on Thursday approved a new type of pain pill designed to eliminate the risks of addiction and overdose ...

The FDA's approval process for Journavx included an evaluation of its safety and efficacy. Clinical trials demonstrated that the drug is effective in managing acute pain without the adverse ...

Genentech Inc. won regulatory approval Tuesday to market an eye implant that can be refilled every six months with an already ...

Patented genetics from Charlotte’s Web were used in the process. There are very rare instances when cannabis-based drug candidates have achieved FDA approval, with only one containing cannabis ...

People with treatment-resistant depression can now take Spravato's ketamine-derived nasal spray as a standalone treatment.

That gave the FDA a way to communicate expectations to drugmakers about how clinical trials should be conducted to support a drug approval ... There is a formal process for removing guidance ...

At the end of 2024, more than 50 authorized treatment centers in the U.S. had initiated the treatment process with over 50 patients. In December, the FDA approved Alyftrek, a new once-daily pill ...