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evobrutinib

- PMLiVE

FDA questions safety profile of AZ, FibroGen’s anaemia drug roxadustat

AZ and FibroGen are aiming for approval of roxadustat in anaemia caused by chronic kidney disease

Biogen Idec building

Biogen pays InnoCare $125m upfront for potential multiple sclerosis treatment

Orelabrutinib is currently being evaluated in a phase 2 trial in relapsing-remitting MS

- PMLiVE

FDA acting commissioner Janet Woodcock requests independent review of Aduhelm approval

Approval of Biogen's Alzheimer's disease treatment has raised concerns over FDA staff interactions with the company

- PMLiVE

Pfizer, BioNTech eye US approval for COVID-19 booster dose

Companies plan to request an emergency use authorisation from the FDA for the booster dose in August

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

Biogen Idec building

Biogen reveals new data for MS therapies Tysabri and Vumerity

New data comes ahead of FDA decision on company's controversial Alzheimer’s drug aducanumab

Roche Basel Switzerland

Roche’s Ocrevus shows significant benefit in early-stage MS patients

The data was presented virtually at the American Academy of Neurology annual meeting

- PMLiVE

Novartis gains EU approval for relapsing MS drug Kesimpta

The drug reduces the number of confirmed relapses in MS patients

- PMLiVE

J&J’s multiple sclerosis therapy Ponvory moves closer to EU approval

CHMP issues a positive opinion for S1P1 modulator based on positive phase 3 results

- PMLiVE

J&J’s MS drug ponesimod receives approval in the US

US regulator has approved the drug – now named Ponvory – for relapsing forms of MS

- PMLiVE

FDA advisory committee to review oncology accelerated approvals

Review comes after voluntary indication withdrawals for a number of cancer therapies

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