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- PMLiVE

Santhera

Roche Basel Switzerland

FDA approval for Roche diagnostic solid tumour test

Test will identify which patients could benefit from GSK immunotherapy.

- PMLiVE

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

- PMLiVE

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

- PMLiVE

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

- PMLiVE

Sarepta Therapeutics’ DMD gene therapy shows early success

Most patients with Duchenne muscular dystrophy require full-time use of a wheelchair by their early teens

- PMLiVE

FDA advisory committee to review oncology accelerated approvals

Review comes after voluntary indication withdrawals for a number of cancer therapies

- PMLiVE

Lilly links up with Precision BioSciences in genome editing deal

Precision will receive an upfront cash payment of $100m

- PMLiVE

Solid Bio axes staff by one-third as it clings to troubled DMD programme

Extends company's cash runway up until 2021

Roche Basel Switzerland

Roche pays $1.15bn for Sarepta’s Duchenne gene therapy

Pens another gene therapy deal following takeover of Spark Therapeutics

- PMLiVE

Wave’s challenge to Sarepta in Duchenne falls flat

Shares in the company down more than 50%

- PMLiVE

FDA grants surprise OK to Sarepta’s DMD therapy after earlier rejection

Initially had concerns about infection risks and kidney toxicity

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