Pharmafile Logo
T40 2022 Cover
Diversity, Equity and Inclusion
Communiqué 53 Cover Image
- PMLiVE

soft tissue sarcoma

- PMLiVE

FDA delays BMS’ liso-cel decision, citing COVID-19 travel restrictions

Inspection of third-party manufacturing plant delayed due to COVID-19

Sanofi reception

Sanofi’s quadrivalent flu vaccine Supemtek scores EU approval

Company expects first EU launches in 2022/2023 flu season

- PMLiVE

FDA set to publish reviews of data relating to COVID-19 vaccine EUAs

Agency set to publish data as part of 'transparency' efforts

Roche Basel Switzerland

Roche’s flu pill Xofluza moves closer towards EU approval

CHMP recommends drug for approval in the EU

- PMLiVE

EU secures 405 million doses of CureVac’s COVID-19 vaccine

CureVac revealed early stage data for its vaccine earlier this month

- PMLiVE

Sobi’s Gamifant receives final rejection from CHMP for primary HLH

Committee reiterated previous negative opinion

EU flag

EU agrees on supply deal for 200 million doses of Pfizer, BioNTech’s COVID-19 vaccine

European Commission will have an option to request another 100 million doses

- PMLiVE

FDA advisory committee overwhelmingly votes no on Biogen’s aducanumab

Path to approval looks increasingly difficult for potential Alzheimer’s treatment

- 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’

- PMLiVE

The Unknown Unknowns

Patient insights are fundamental to ensuring we understand the reality of living with a condition. We need to consciously  challenge our approach and ensure we are unearthing authentic patient insights that...

Bedrock Healthcare Communications

- PMLiVE

COVID-19 vaccine developers won’t face pre-approval FDA inspections for EUAs

Companies typically face inspections before gaining approval from the FDA

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links