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- PMLiVE

roxadustat

- PMLiVE

Takeda’s subcutaneous Entyvio formulation faces FDA rejection

Was seeking approval in moderate-to-severe ulcerative colitis

- PMLiVE

FDA follows EMA with approval of Merck’s Ebola vaccine

First to be approved in the US

- PMLiVE

Trump administration advances drug importation plan

Proposal would allow states to import drugs from Canada

- PMLiVE

AZ, Merck’s Lynparza narrowly scores FDA approval for pancreatic cancer

Committee voted seven to five in favour of PARP inhibitor

- PMLiVE

GSK files anti-BCMA drug for myeloma after second trial win

Important drug for GSK as it rebuilds R&D pipeline

- PMLiVE

UPDATED: Senate officially confirms Stephen Hahn as FDA commissioner

Final Senate vote was 72 to 18 in favour of the radiation oncology expert

- PMLiVE

Horizon looks bright as FDA panel backs eye drug teprotumumab

First alternative to surgery for proptosis

- PMLiVE

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

Initially had concerns about infection risks and kidney toxicity

- PMLiVE

AZ, Daiichi Sankyo strengthen case for HER2 candidate

Will rival Roche's HER2 franchise if approved

- PMLiVE

AstraZeneca’s Calquence impresses in previously untreated CLL

Takes the fight to AbbVie/J&J’s Imbruvica

- PMLiVE

Biogen defends aducanumab filing plan amid scepticism

A new look at pivotal trial data described as hard-to-interpret

- PMLiVE

Lynparza cleared for first-line ovarian cancer use in China

Continues to cement lead in PARP inhibitor category

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