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FDA and CDC investigate potential safety concern for Pfizer/BioNTech’s COVID-19 vaccine

Preliminary data showed a possible link between the updated vaccine and a higher risk of stroke

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GSK and CureVac to advance mRNA COVID-19 and flu vaccine candidates

The vaccines produced promising preliminary results in phase 1 trials

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

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

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WHO reports new Omicron subvariant cases detected in 29 countries worldwide

The new Omicron subvariant is spreading rapidly in the US

- PMLiVE

Valneva reports additional data for COVID-19 booster

VLA2001 was well tolerated in participants previously vaccinated with an mRNA vaccine

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Novavax initiates phase 2 combination COVID-19/flu vaccine study

Initial results from the trial are expected towards the middle of the year

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RQ Bio-discovered antibody enters clinic as part of AstraZeneca COVID-19 study

The trial will evaluate the UK-based biotech’s AZD3152 in combination with cilgavimab

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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

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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

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CHMP recommends use of Moderna’s Omicron BA.1 booster in children in the EU

The company is also evaluating the use of the vaccine in children aged from six months

- PMLiVE

WHO joins calls for equitable access to healthcare products ahead of future pandemics

The WHO, WIPO and WTO gathered at the Joint Technical Symposium on 16 December

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