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- PMLiVE

soft tissue sarcoma

- PMLiVE

CHMP recommends eight new medicines for EU approval

BMS’ CAR T therapy Abecma and BioMarin’s dwarfism drug Voxzogo among positive recommendations

Biogen Idec building

Biogen plans confirmatory trial as FDA documents show struggle over Aduhelm approval

Confirmatory trial is planned to be completed ahead of nine-year time frame

- PMLiVE

BMS’s oral AML therapy Onureg receives EU approval

Onureg is the oral version of Vidaza, two of the drugs BMS gained as part of its acquisition of Celgene in 2019

Sanofi reception

Sanofi’s oral therapy Aubagio approved in the EU for paediatric MS patients

EC approval comes a few weeks after the FDA rejected Aubagio in the same patient population

- PMLiVE

Court rules on AZ and EU’s COVID-19 vaccine dispute

The Court in Brussels has ordered AZ to deliver a total of 80.2 million doses to the EU by 27 September 2021

- PMLiVE

FDA approves Biogen’s aducanumab for Alzheimer’s disease in ‘landmark’ decision

FDA is requiring Biogen to conduct a new randomised, controlled clinical trial to verify the drug’s clinical benefit for Alzheimer’s patients

- PMLiVE

Moderna seeks full FDA approval for its COVID-19 vaccine

Moderna's mRNA-based vaccine is currently authorised for emergency use in the US

- PMLiVE

BMS’ Zeposia gains FDA approval in ulcerative colitis

Treatment was initially approved in 2020 for multiple sclerosis

- PMLiVE

EMA authorises Pfizer/BioNTech’s COVID-19 vaccine for children aged 12 to 15

Clinical trial data recently showed that the vaccine is safe and effective in individuals in this age group

- PMLiVE

AZ’s Tagrisso approved for EGFR-positive NSCLC in the EU

European Commission approved Tagrisso in this setting based on positive results from the ADAURA phase 3 study

- PMLiVE

FDA panel backs Provention Bio’s type 1 prevention drug teplizumab

Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) narrowly voted in favour of supporting approval of the drug

- PMLiVE

EU takes legal steps against AZ over delayed COVID-19 vaccine deliveries

Lawyers for the European Commission have asked the court to fine AZ €10m per infraction

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