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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

Merck submits 15-valent pneumococcal vaccine candidate to EMA and FDA

If approved, this vaccine will closely challenge Pfizer's Prevnar-13

- 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

Merck strengthens oncology pipeline with $2.75bn VelosBio deal

The deal will give Merck control of VLS-101, an antibody-drug conjugate

- 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’

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