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- PMLiVE

Viaskin Peanut

- PMLiVE

Ironwood claims FDA OK for former AZ gout drug

Duzallo will be launched in the US before the end of this year

- PMLiVE

Setback for J&J as FDA panel turns down arthritis drug sirukumab

US regulator concerned with the drug’s safety

AstraZeneca AZ

Clock starts ticking on FDA review of AZ’s acalabrutinib

If approved, the BTK inhibitor could achieve annual peak sales of $5bn

Living in fear

An evolutionary perspective reduces the risk  of missing something very important

AstraZeneca AZ

After MYSTIC setback, FDA gives some comfort to AZ

Awards its PD-L1 inhibitor Imfinzi breakthrough status in locally-advanced NSCLC

Eli Lilly HQ

Baricitinib delay casts a pall over Lilly’s results update

FDA requests further data that could keep the drug off the market for a couple of years

Bristol Myers Squibb logo

BMS wins first US immuno-oncology paediatric licence

FDA gives the green light to expanded use of its melanoma treatment Yervoy

- PMLiVE

Gilead gets OK for three-in-one hep C therapy in US

FDA clears the new product for the most common HCV genotypes

- PMLiVE

Spark closes on first US gene therapy approval

FDA starts review of Luxturna for patients with inherited retinal disease

- PMLiVE

FDA rejects Amgen’s osteoporosis hope romosozumab

Its partner UCB plans to submit the medicine for European approval later this year

- PMLiVE

Amgen aspires to new Kyprolis label in the US and Europe

Appeals to regulators to add survival data to multiple myeloma drug's labelling

- PMLiVE

FDA panel backs Avastin and Herceptin biosimilars

A decision from the US regulator is expected in September

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