StockWatch: FDA Panel Enables Accelerated OK for Biogen ALS Drug
Mixed votes from an FDA advisory panel may help Biogen secure accelerated approval of ALS drug tofersen, licensed from Ionis Pharmaceuticals.
Source: genengnews.com
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'Pregnancy Isn't an Illness': Judge to Decide 'Soon' if FDA Violated Safety Rules on Abortion Drug
A federal judge pressed both sides in a hearing on Wednesday questioning FDA approval of an abortion drug.
Source: cbn.com
HHS to Create New Potential Medicare Pricing Models for Cell and Gene Therapy, Drugs Subject to Accelerated FDA Approval, and "High-Value" Generics | Goodwin
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...
Source: jdsupra.com
Cornyn Blasts Biden Admin's Innovation-Killing Drug Pricing Model
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.
Source: texasgopvote.com
A Revolution in the Treatment Landscape of AD
Andrew N. Wilner, MD, and Richard J. Caselli, MD, discuss developments in the treatment of Alzheimer's disease.
Source: medscape.com