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- PMLiVE

Asunaprevir

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AcelRX’s potent opioid tablets set to win FDA backing for pain relief

Panel voted 10 to 3 in favour of the treatment

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BMS finds a new immunotherapy partner with $12m Compugen deal

Combination with novel antibody targeting PVRIG pathway

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Insmed claims first FDA okay for limited population antibiotic

Arikayce is cleared to treat lung disease caused by MAC

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Alnylam seeks fast-track filing with biomarker data

Early filing reflects FDA desire for faster approvals

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Alexion adds to pipeline with $1.2bn Syntimmune buy

As company prepares for possible loss of patent protection for Soliris

Bristol Myers Squibb logo

BMS psoriasis drug hits the mark in phase II

Tyrosine kinase 2 (Tyk2) inhibitors could play major role

- PMLiVE

FDA gives Loxo breakthrough tag for second cancer drug

US regulatory body to expect a NDA for LOXO-292 in late 2019

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Daily Brief: setback for Akcea/Ionis, Urovant adds gene therapy, Metrion gains funding

FDA rejects Waylivra, Roivant group continues gene therapy drive, UK biotech gains £637k

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Shire claims US okay for HAE blockbuster-in-waiting

FDA approves Takhzyro as a preventative measure for HAE attacks

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FDA green lights BMS’ Opdivo for ‘hard-to-treat’ small cell lung cancer

Becomes the first checkpoint inhibitor for this indication

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FDA clears Kyowa Kirin’s skin lymphoma therapy Poteligeo

Becomes the first drug approved to treat Sézary syndrome

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FDA’s Gottlieb lambasts industry’s biosimilar-blocking tactics

Speech coincides with Biosimilars Action Plan

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