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- PMLiVE

Wilson Therapeutics

- PMLiVE

Diurnal files adrenal insufficiency drug Alkindi in US

Could become only treatment for children with the condition

- PMLiVE

Roche’s Soliris rival satralizumab scores in phase 3 study

Therapy has been filed in US and Europe with decisions expected in 2020

- PMLiVE

Incyte claims FDA priority review for bile duct cancer drug

Significant need for new therapies in hard-to-treat cancer type

- PMLiVE

FDA backs GBT’s sickle cell drug Oxbryta

Second new treatment for blood disorder to be approved this year

- PMLiVE

Roche scores FDA priority review for risdiplam in SMA

Potential rival to Novartis’ Zolgensma and Biogen’s Spinraza

- PMLiVE

FDA clears SK Life Science’s anti-epileptic drug Xcopri

Significantly reduced the frequency of seizures at all doses studied

- PMLiVE

FDA clears Alnylam’s second RNAi drug for rare disease

Second drug in the class to be cleared by regulatory authority

- PMLiVE

BeiGene bags FDA approval for first product Brukinsa in lymphoma

Also the first approval for a Chinese-developed cancer drug in US

- PMLiVE

Amarin wins FDA advisory nod for Vascepa cardiovascular expansion

Approval likely for fish-oil derived drug following speedy review

- PMLiVE

Aveo’s tivozanib is knocked back by FDA once again

Company says it will delay any regulatory filing until first quarter next year

- PMLiVE

MD Anderson exec Stephen Hahn to be nominated FDA commissioner

US President Trump scouts well-known oncology expert to lead agency

Roche Basel Switzerland

US, EU regulators start review of Roche’s Soliris rival satralizumab

Sets up a possible market clash with Alexion next year

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