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- PMLiVE

naloxone

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Gilead’s Trodelvy granted FDA priority review for metastatic breast cancer

Phase 2 study results showed a 34% reduction in risk of disease progression or death

- PMLiVE

GSK’s Boostrix approved by FDA for use during pregnancy to prevent whooping cough in infants

4.2% of the cases of pertussis reported in the US in 2021 were in infants younger than six months

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FDA approves scPharmaceuticals’ on-body infusor for congestive heart failure

The at-home device delivers the equivalent of what a patient would receive by way of IV

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AbbVie’s Allergan reaches proposed $2.37bn agreement to settle US opioid lawsuits

Together with Teva Pharmaceutical’s proposed $4.25bn deal, the total settlement deal could be worth $6.6bn

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Teva reaches proposed $4.25bn agreement to settle US opioid lawsuits

The figure includes the supply of up to $1.2bn of Teva’s Narcan, a life-saving medication which can reverse an overdose from opioids

- PMLiVE

FDA lifts hold on Gilead’s clinical trials for leukaemia

Following a review of the safety data, enrolment can be resumed for the MDS and AML clinical trials

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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FDA leaders offer perspective on accelerated approval of Biogen’s Aduhelm

Leaders maintain that Aduhelm fits into the regulatory paradigm of the FDA’s accelerated approval pathway

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FDA questions safety profile of AZ, FibroGen’s anaemia drug roxadustat

AZ and FibroGen are aiming for approval of roxadustat in anaemia caused by chronic kidney disease

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FDA acting commissioner Janet Woodcock requests independent review of Aduhelm approval

Approval of Biogen's Alzheimer's disease treatment has raised concerns over FDA staff interactions with the company

- PMLiVE

Pfizer, BioNTech eye US approval for COVID-19 booster dose

Companies plan to request an emergency use authorisation from the FDA for the booster dose in August

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