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- PMLiVE

cerebral adrenoleukodystrophy

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

- PMLiVE

Novartis’ CAR-T clears FDA panel with relative ease

Puts tisagenlecleucel-T on course to be first approved personalised CAR-T therapy

- PMLiVE

FDA halts third Merck myeloma trial after patient deaths

More patients died on Keytruda combination than those on other treatments

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