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

Mrs. Thomas’ pharmacist explained the generic process to her and she ... The U.S. Food and Drug Administration (FDA) has given approval to Aurobindo Pharma Ltd., Dr. Reddy’s Laboratories ...

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

The next FDA Commissioner could solve two big problems with one powerful policy: encourage independent testing of both ...

Trump's pick for HHS secretary who endured confirmation hearings last week—has repeatedly criticized industry ties to the FDA ...

Tuesday, the agency signed off on SpringWorks’ Gomekli (mirdametinib) as a treatment for the rare genetic disorder ...

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

Terra Wonsettler, PharmD, MBA, vice president of pharmacy for Evolent, discusses the recent HHS OIG report that stemmed from ...

NKGen is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic NK cell therapeutics. NKGen is headquartered in Santa Ana, ...

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