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Dsuvia

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FDA approves Seagen/Genmab’s antibody-drug conjugate Tivdak for women with advanced cervical cancer

The drug has been granted accelerated approval, and the companies have also released positive data on first-line treatment

- PMLiVE

Sanofi boosts transplant portfolio with newly approved Rezurock

Sanofi’s acquisition of Kadmon Holdings adds Rezurock to its transplant portfolio in a deal worth $1.9bn.

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

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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.

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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

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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

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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

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