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Xenazine

- PMLiVE

FDA takes aim at pharma’s biosimilar-delaying tactics

Ever-rising cost of insulins also to be targeted

- PMLiVE

FDA clears Sandoz and Pear’s Opioid Use Disorder app

The app incorporates CBT to improve high relapse rates

- PMLiVE

Pfizer claims rapid FDA nod for Lorbrena

Green light is latest in a string of cancer drug approvals

- 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

Teva wins FDA OK for crucial migraine drug

Vital to Teva's turnaround, Ajovy will challenge Novartis/Amgen's Aimovig

- PMLiVE

FDA gives Loxo breakthrough tag for second cancer drug

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

- 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

Roche's Perjeta pertuzumab

Daily Brief: Biosimilar Herceptin can’t make Perjeta cost effective and more

E-cigarettes can save lives - Teva gains approval for EpiPen generic

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