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- PMLiVE

soft tissue sarcoma

- PMLiVE

AZ seeks EU approval for its Oxford University-partnered COVID-19 vaccine

CHMP could reach a decision on opinion by 29 January

- PMLiVE

Moderna wins EU authorisation for COVID-19 vaccine

EU Commission approval comes on the same day as positive CHMP opinion

- PMLiVE

Roche’s tiragolumab plus Tecentriq combo wins FDA breakthrough therapy designation

Swiss pharma is aiming for approval in first-line NSCLC

Biogen Idec building

New intramuscular administration for Biogen’s MS therapy Plegridy approved in the EU

New administration offers same efficacy as subcutaneous injection

- 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

Roche Basel Switzerland

Roche gets EU approval for fixed-dose Herceptin/Perjeta combination

Treatment can be administered as an injection instead of an intravenous infusion

- 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

EU authorises Aimmune’s peanut allergy treatment Palforzia

Approval in the EU comes nine months after US authorisation

- 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

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