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- PMLiVE

Krystal Biotech

- 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

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”

- 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

FDA requests further safety trials for AZ, FibroGen’s roxadustat

The response follows concerns over serious thrombotic events and seizures

- PMLiVE

Gene therapy company bluebird bio quits Europe

The decision comes after a trial in a rare neurological disease is halted over safety concerns and the FDA has placed the eli-cel programme on clinical hold

- PMLiVE

Roche engaged in talks with FDA for Alzheimer’s drug candidate

CEO Severin Schwan told reporters Roche will complete a phase 3 trial of gantenerumab in the second half of 2022

- PMLiVE

Merck, Eisai’s Keytruda/Lenvima regimen scores full approval in endometrial cancer

Keytruda plus Lenvima was previously approved under the FDA’s accelerated approval process

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