Market Access News | pharmaphorum

News

engineering and genetic editing through the Crispr technique. DNA chain breaking down. 3D rendering

NICE rejects Orchard's gene therapy for rare childhood disea...

Orchard Therapeutics' gene therapy for rare childhood disease metachromatic leukodystrophy (MLD) Libmeldy has been rejected for NHS use by NICE in draft guidance.

News

FDA whittles back Aduhelm approval amid concern over broad l...

One of the criticisms levelled at the FDA over its approval of Biogen and Eisai's Alzheimer's disease drug Aduhelm was its decision to clear use of the drug in a broader group of patients t

News

AZ, Amgen get speedy FDA review for asthma drug tezepelumab

The FDA has started a priority review of AstraZeneca and Amgen's severe asthma antibody tezepelumab, setting a date for a decision in the first quarter of 2022.

News

FDA rejects Provention's type 1 diabetes drug teplizumab

The FDA indicated something was not well with Provention Bio's filing for type 1 diabetes therapy teplizumab in April when it delayed its review.

News

Novartis tries to rescue stalled inclisiran filing with FDA

Novartis has tried to get its marketing application for high cholesterol therapy inclisiran in the US back on track, after the FDA rejected it last year, by changing the factory that makes

News

Zydus Cadila nears world-first human plasmid DNA vaccine app...

Zydus Cadila has filed for emergency use approval (EUA) in India of its plasmid DNA-based vaccine for COVID-19, which if given a green light could become the first shot of its type to be cl

NICE rejects Orchard's gene therapy for rare childhood disea...

FDA whittles back Aduhelm approval amid concern over broad l...

AZ, Amgen get speedy FDA review for asthma drug tezepelumab

FDA rejects Provention's type 1 diabetes drug teplizumab

Novartis tries to rescue stalled inclisiran filing with FDA

Zydus Cadila nears world-first human plasmid DNA vaccine app...

Datroway joins Trodelvy for frontline TNBC in the EU

Discover a new era of healthcare panel engagement: Grounded ...

News

Editor's Picks