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- PMLiVE

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- 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

Roche Basel Switzerland

Roche’s flu pill Xofluza moves closer towards EU approval

CHMP recommends drug for approval in the EU

- PMLiVE

Sobi’s Gamifant receives final rejection from CHMP for primary HLH

Committee reiterated previous negative opinion

- PMLiVE

AZ, Amgen’s investigational asthma drug comes good in phase 3

Tezepelumab evaluated in late-stage trial of severe asthma patients

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