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- PMLiVE

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

Panel voted 10 to 3 in favour of the treatment

- PMLiVE

Insmed claims first FDA okay for limited population antibiotic

Arikayce is cleared to treat lung disease caused by MAC

- PMLiVE

Alnylam seeks fast-track filing with biomarker data

Early filing reflects FDA desire for faster approvals

- PMLiVE

Alexion adds to pipeline with $1.2bn Syntimmune buy

As company prepares for possible loss of patent protection for Soliris

- PMLiVE

FDA gives Loxo breakthrough tag for second cancer drug

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

Sanofi reception

Sanofi gets EU OK for Ablynx flagship drug Cablivi

EMA clears the drug to treat adults with aTTP

- PMLiVE

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

- PMLiVE

Shire claims US okay for HAE blockbuster-in-waiting

FDA approves Takhzyro as a preventative measure for HAE attacks

- PMLiVE

FDA clears Kyowa Kirin’s skin lymphoma therapy Poteligeo

Becomes the first drug approved to treat Sézary syndrome

- PMLiVE

Dupixent bounce-back helps stem diabetes declines at Sanofi

CEO Brandicourt says Sanofi will “enter a new growth phase”

- PMLiVE

Ashfield and Sanofi scoop ICE award

Company wins the Most Effective Agency Collaboration Award for the second year running

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