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FDA accepts Regeneron’s REGEN-COV for priority review for treatment of COVID-19

In Europe, the EMA will review a Marketing Authorisation Application for the antibody cocktail

- PMLiVE

Positive data for Lyme disease booster vaccine

A booster shot of Valneva/Pfizer’s VLA15 vaccine candidate against tick-borne Lyme disease demonstrates a strong immune response

- PMLiVE

COVID-19 Pfizer/BioNTech booster approved by FDA and CDC

The plan to offer Americans a third, booster shot of the Pfizer/BioNTech COVID-19 vaccine has finally been waved through by the FDA and CDC

- PMLiVE

UK announces COVID boosters for a “bumpy winter” ahead

A single shot of Pfizer’s COVID-19 vaccine will be offered to 30 million people in the UK including those 50 or over and frontline health and social care workers

- PMLiVE

Future of MHRA uncertain amid Brexit-fuelled shake up

Trade unions and regulatory experts warn that budget and staff cuts may lead to drug approval delays or the UK regulator simply rubber-stamping EMA decisions

- PMLiVE

Pfizer starts RSV trial ahead of winter season

A vaccine against the common respiratory syncytial virus could be available soon, as Pfizer joins GSK and J&J in launching phase 3 trials

- PMLiVE

Pfizer/BioNTech file for FDA approval for COVID-19 booster jab

New data shows third dose boosts antibodies by more than three times

- PMLiVE

Pfizer to acquire Canadian immuno-oncology company Trillium in a deal worth $2.6bn

The deal will strengthen Pfizer’s oncology offering and follows an investment of $25m in Trillium made by Pfizer in January

- PMLiVE

Pfizer/BioNTech submit data for COVID-19 booster shots

Booster shots are expected to be approved quickly in the US, as cases of delta variant surge

- PMLiVE

Aspirin to be trialled as part of new treatment for triple negative breast cancer

Immunotherapy drug Avelumab plus aspirin could help control tumour growth

- PMLiVE

CureVac to push ahead with first- and second-generation COVID-19 vaccines

The biotech will seek EMA approval for first-generation jab while trials are due to start for second-generation jabs in Q4

- PMLiVE

EMA to evaluate Roche arthritis drug RoActemra for severe COVID-19

FDA approval has already been granted following positive phase 3 trials

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