Pharmafile Logo
T40 2022 Cover
Diversity, Equity and Inclusion
Communiqué 53 Cover Image
- PMLiVE

Cornerstone

- PMLiVE

FDA expert panel recommends EUA for Pfizer/BioNTech COVID-19 vaccine

Formal approval in the US could follow 'within days'

- PMLiVE

FDA briefing document paves the way for Pfizer/BioNTech COVID-19 vaccine approval

Advisory Committee is set to meet today to discuss vaccine's safety and efficacy data

- PMLiVE

Novavax moves closer toward launch of US phase 3 COVID-19 vaccine trial

Company also completes enrolment in UK-based phase 3 trial

Roche Basel Switzerland

Roche’s Xofluza pill wins FDA approval for post-exposure flu prevention

First single-dose flu medication approved for post-exposure prophylaxis

- PMLiVE

FDA sets 10 December date for Pfizer’s COVID-19 vaccine meeting

Independent experts will discuss EUA submission for mRNA-based vaccine

regeneron headquarters

Regeneron’s COVID-19 antibody cocktail scores FDA emergency approval

Drug approved to treat high-risk patients with mild to moderate COVID-19

- PMLiVE

Pfizer, BioNTech to submit emergency use request for COVID-19 vaccine to FDA today

Shot could be available for high-risk populations in the US by middle of December

- PMLiVE

FDA delays BMS’ liso-cel decision, citing COVID-19 travel restrictions

Inspection of third-party manufacturing plant delayed due to COVID-19

- PMLiVE

FDA set to publish reviews of data relating to COVID-19 vaccine EUAs

Agency set to publish data as part of 'transparency' efforts

- PMLiVE

FDA advisory committee overwhelmingly votes no on Biogen’s aducanumab

Path to approval looks increasingly difficult for potential Alzheimer’s treatment

- PMLiVE

EMA will assess potential COVID-19 vaccine on ‘case by case’ basis

Agency will not specify a minimum level of efficacy, according to Reuters

- PMLiVE

FDA briefing documents back Biogen’s Alzheimer’s drug aducanumab

Documents show the efficacy data for the drug as being ‘exceptionally persuasive’

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links