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- PMLiVE

Prevention Bio

- 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 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

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

bluebird bio sells Rare Pediatric Disease Priority Review Voucher

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

- PMLiVE

BioNTech and Ryvu partner to develop immuno-modulatory small molecule candidates

The focus will be on immune modulation within oncology and potentially other disease areas

- PMLiVE

Pfizer/BioNTech BA.4/BA.5 COVID-19 booster receives CHMP recommendation for children five to 11 years

If an authorisation is granted, doses of the bivalent booster will be available to all 27 EU member states

- PMLiVE

Pfizer and BioNTech dose first patient in COVID-19/flu combination vaccine study

The vaccine aims to protect individuals against two severe respiratory viral diseases

- PMLiVE

Pfizer/BioNTech BA.4/BA.5 COVID-19 booster approved for emergency use by FDA in children five to 11 years

The doses will be shipped immediately, pending recommendation from the CDC

- PMLiVE

Pfizer and BioNTech seek FDA authorisation for COVID-19 booster for children

An application will also be submitted to the European Medicines Agency to extend the marketing authorisation for this age group

- PMLiVE

bluebird bio’s Skysona approved by FDA to treat cerebral adrenoleukodystrophy

The gene therapy was shown to slow the progression of neurologic dysfunction

- PMLiVE

Pfizer/BioNTech BA.1 COVID-19 booster receives CHMP recommendation

If an authorisation is granted, doses of the bivalent booster will be available to all 27 EU member states

- PMLiVE

bluebird bio’s beta-thalassaemia gene therapy receives FDA approval

Patients with the most severe form of the blood disorder develop life-threatening anaemia and have to receive regular blood transfusions

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