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- PMLiVE

Generic Pharmaceutical Association

- PMLiVE

FDA will not alter dosing schedules for authorised COVID-19 vaccines

Time period between first and second vaccines has been extended in the UK

- PMLiVE

Inovio plans late-stage COVID-19 vaccine study in second quarter 2021

FDA had placed trial on a temporary hold in September 2020

- PMLiVE

Growing evidence supports the important role of biosimilars in healthcare

New data released at the ASCO Quality Care Symposium continues to underscore the cost-effectiveness of biosimilar treatment options in cancer care

- PMLiVE

FDA approves Myovant’s oral pill Orgovyx for prostate cancer

This is a new option for advanced prostate cancer patients in the US

- PMLiVE

Moderna receives FDA emergency authorisation for its COVID-19 vaccine

Moderna's vaccine is the second to receive FDA approval, following approval of Pfizer/BioNTech’s BNT162b2 vaccine

- PMLiVE

Amgen aims for first KRAS inhibitor approval in the US

Sotorasib is a potential treatment for advanced KRAS G12C-mutated NSCLC

- PMLiVE

Moderna scores FDA panel backing for mRNA-based COVID-19 vaccine

EMA also brings forward review meeting of vaccine

- PMLiVE

Novartis receives FDA breakthrough therapy designation for rare disease med

The Swiss pharma company is eyeing approval in PNH and C3G indications

- PMLiVE

FDA experts back safety and efficacy of Moderna’s COVID-19 vaccine

Briefing document published ahead of advisory committee meeting

- 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

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