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- PMLiVE

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Biomarin

FDA pauses BioMarin gene therapy trial

The study for BMN 307 in genetic disease phenylketonuria will be paused while malignancies in mice are explored

- PMLiVE

Congress “concerned by apparent anomalies” around FDA’s approval of Aduhelm

Congress demands more information from the FDA on its controversial approval of Biogen’s Alzheimer’s drug and its dealings with the company.

- PMLiVE

FDA experts to evaluate Pfizer-BioNTech COVID-19 booster

As Moderna announces it has submitted COVID-19 vaccine booster data, the FDA advisory committee of outside experts will convene in two weeks’ time

- PMLiVE

FDA nod for Janssen schizophrenia treatment Invega Hafyera

The phase 3 study results showed that 92% of patients were relapse-free after 12 months

- PMLiVE

FDA’s director and deputy director of its Office of Vaccines Research & Review resign

The departure of director Marion Gruber and deputy director Philip Krause is unexpected

- PMLiVE

Merck’s Keytruda gains two more approvals in Japan

New approvals in breast and colorectal cancer take the number of indication for the immunotherapy mega-blockbuster to 15 in Japan

- 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

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”

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