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

Monkeypox

- PMLiVE

Bavarian Nordic’s COVID-19 booster ‘not suitable’ for emerging variants

Results showed that ABNCoV2 was not as effective against the circulating XBB.1.5 variant

dengue fever mosquito

Bavarian Nordic’s chikungunya vaccine candidate shows promise in late-stage trial

There is currently no approved vaccine or specific treatment for chikungunya virus infections

- PMLiVE

bluebird bio sells second FDA priority review voucher for $95m

The company sold its first voucher to Dutch biotech Argenx for $102m

- PMLiVE

FDA approves Ferring’s Adstiladrin as first gene therapy for bladder cancer

Non-muscle-invasive bladder cancer represents around 75% of all new bladder cancer cases

- PMLiVE

Roche’s COVID-19 antibody receives FDA approval for hospitalised adults

The decision makes Actemra the first FDA-approved monoclonal antibody to treat COVID-19

- PMLiVE

FDA lifts partial clinical hold on bluebird bio’s sickle cell gene therapy studies

The company can now resume the enrolment and treatment of patients aged two to 17 years

- PMLiVE

FDA approves updated COVID-19 boosters for children aged from six months

The Moderna and Pfizer/BioNTech boosters both target the BA.4/BA.5 omicron subvariants

- PMLiVE

Pfizer’s RSV vaccine candidate accepted for FDA priority review for use in older adults

A phase 3 study showed the vaccine was 85.7% effective in those with three or more symptoms

- PMLiVE

Pfizer/BioNTech submit FDA application for BA.4/BA.5 COVID-19 vaccine in children under five

The vaccine is already authorised as a booster for ages five years and older in the US and EU

- PMLiVE

FDA approves Rigel’s Rezlidhia for acute myeloid leukaemia

Phase 2 data showed a complete remission rate of 35% and median duration of 25.9 months

- PMLiVE

FDA approves Scynexis’ Brexafemme for recurrent vulvovaginal candidiasis

The antifungal is already approved in the US for vulvovaginal candidiasis

- PMLiVE

bluebird bio sells Rare Pediatric Disease Priority Review Voucher

The company was granted two PRVs upon the FDA approvals of Zynteglo and Skysona

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links