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- PMLiVE

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- PMLiVE

FDA’s approval of Pfizer/BioNTech’s COVID-19 vaccine “is a milestone” says acting FDA commissioner Janet Woodcock

After more than a billion doses have been given worldwide, Comirnaty is now officially approved for people aged 16 and over in the US

- PMLiVE

FDA to consider BMS’ Orencia for graft versus host disease

Leukaemia patients who receive stem cell transplant may gain access to Orencia by the end of the year

- PMLiVE

AZ to seek approval for “long-acting” COVID-19 antibodies

AZD7442 significantly reduced the risk of developing symptomatic COVID-19 in phase 3 trial and is a one-dose treatment that can be given via an intramuscular injection

- PMLiVE

COVID-19 vaccine protection wanes over time, backing up the need for boosters

While both Pfizer/BioNTech and AstraZeneca’s vaccines offer good protection, a new UK study shows the protection reduces over time and the UK's booster campaign is likely to begin in September

Roche Basel Switzerland

FDA approval for Roche diagnostic solid tumour test

Test will identify which patients could benefit from GSK immunotherapy.

Roche Basel Switzerland

FDA approval for Roche diagnostic solid tumour test

Test will identify which patients could benefit from GSK immunotherapy.

- PMLiVE

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

FDA approval has already been granted following positive phase 3 trials

- PMLiVE

FDA opens door to COVID-19 booster jabs

FDA approves third shot of mRNA vaccine for the immunocompromised but EMA says there’s “not yet enough data”

- PMLiVE

Price hike for Pfizer/BioNTech COVID-19 vaccine as UK orders boosters for 2022

The UK will pay £22 a shot, up from £18 previously, as confirmation of the UK's COVID-19 booster campaign for this winter is awaited, while the EU and the US...

- PMLiVE

FDA grants orphan drug status to Allogene’s BCMA-targeted treatment for multiple myeloma

The decision follows the RMAT designation granted by the FDA in April

- PMLiVE

Valneva’s COVID-19 vaccine to be tested in older people

The trial for VLA2001 will involve people over the age of 56 in New Zealand and aims to generate additional safety and immunogenicity data in older people

- PMLiVE

South Korean company SK bioscience moves into phase 3 trials for its COVID-19 vaccine

Part of the Wave 2 vaccine programme, GBP510 will bolster South Korea’s domestic supply if successful

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