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- PMLiVE

AveXis

- 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

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

Important drug for GSK as it rebuilds R&D pipeline

- PMLiVE

Gilead’s NASH hopes crushed as candidates fail again

Monotherapy and combination regimens produced disappointing results

- PMLiVE

Novartis ditches oral asthma drug after disappointing phase 3 readout

Bad news for Gossamer’s would-be rival DP2 antagonist

- 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

Intec battered as Novartis ducks out of Accordion collaboration

Shares fell by more than 12% after the annoucement

- PMLiVE

Biogen defends aducanumab filing plan amid scepticism

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

- PMLiVE

Novartis strengthens case for its combination asthma drug

Demonstrated significant benefits in uncontrolled asthma patients

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