Market Access News | pharmaphorum

News

FDA sets August decision date for Provention's type 1 diabet...

Shares in Provention Bio cratered last July when the FDA turned down its marketing application for type 1 diabetes therapy teplizumab.

News

NHS grants fast-track access to Takeda's lung cancer drug Ex...

Takeda has secured UK approval for its lung cancer therapy Exkivity, with an NHS access deal that could see it prescribed to patients within the next few weeks.

News

NICE firms up NHS use of Vimizim for Morquio A syndrome

In 2015, NICE said that BioMarin's Vimizim could be used to treat patients with the ultra-rare disease Morquio A syndrome, while real-world data was collected on its efficacy.

News

FDA clears Marinus' Ztalmy as first drug for rare epilepsy

People with CDKL5 deficiency disorder (CDD) now have their first FDA-approved treatment, after the US regulator gave the nod to Marinus Pharma's Ztalmy for the rare genetic form of

News

Moderna follows Pfizer in asking FDA for second COVID booste...

Moderna has asked the FDA for emergency use authorisation for a fourth dose of its mRNA COVID-19 vaccine SpikeVax, following in the footsteps of Pfizer/BioNTech, which filed their Comirnaty

News

Pfizer makes case for fourth COVID jab dose to FDA

Earlier this week, Pfizer chief executive Albert Bourla said that a second booster of its COVID-19 vaccine will be necessary to keep the pandemic under control, and the company has now aske

FDA sets August decision date for Provention's type 1 diabet...

NHS grants fast-track access to Takeda's lung cancer drug Ex...

NICE firms up NHS use of Vimizim for Morquio A syndrome

FDA clears Marinus' Ztalmy as first drug for rare epilepsy

Moderna follows Pfizer in asking FDA for second COVID booste...

Pfizer makes case for fourth COVID jab dose to FDA

Apnimed IPO raises $192m, as three other biotechs set terms

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

News

Editor's Picks