Page 2 - Accelerated Approval Program News Today

Mixed votes from an FDA advisory panel may help Biogen secure accelerated approval of ALS drug tofersen, licensed from Ionis Pharmaceuticals.

A federal judge pressed both sides in a hearing on Wednesday questioning FDA approval of an abortion drug.

On February 14, 2023, the U.S. Department of Health and Human Services (HHS) published a report identifying three models that the Center for Medicare & Medicaid Services’ (CMS) Center...

If proposed and finalized as described, this profound policy shift would inevitably chill incentives for leveraging the FDA’s game-changing expedited regulatory avenue, which has served patients with life-threatening diseases for decades. Later approvals and access delays would follow.

Andrew N. Wilner, MD, and Richard J. Caselli, MD, discuss developments in the treatment of Alzheimers disease.

The Centers for Medicaid and Medicare Services (CMS) announced a model on February 14, 2023 that would allow CMS to pay less for drugs approved via FDA’s accelerated approval pathway...

By Ahmed Aboulenein

The US health department proposed on Tuesday three new pilot projects aimed at lowering prescription drug prices for people enrolled in government health insurance plans.

The Medicaid and CHIP Payment and Access Commission (MACPAC) voted on January 27 to recommend that Congress grant states the ability to limit Medicaid coverage for drugs and biologicals...

These are some of the key legal deal trends to expect from the health care and life sciences industries in 2023.