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- PMLiVE

Xeljanz

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

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

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

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

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

- 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

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

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.

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