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autoimmune neuromuscular disease

- PMLiVE

Amgen’s chronic kidney disease drug Parsabiv cleared in US

Sensipar follow-up is the first therapy to be approved for treatment of sHPT in 12 years

- PMLiVE

Cellectis gets FDA nod for ‘off-the-shelf’ CAR-T trial

Investigational New Drug gets go-ahead for trials in patients with two haematological cancers

- PMLiVE

Keytruda filed for first- and second-line bladder cancer

Merck & Co hopes to gain advantage over Opdivo and Tecentriq with first-line setting

- PMLiVE

Trump talks pricing and manufacturing with pharma

Heads of Celgene, Lilly, Merck & Co, Novartis and trade body PhRMA met at the White House

- PMLiVE

FDA approves Synergy’s constipation drug Trulance

Set to launch by March this year, analysts say the CIC therapy could see sales of $450m by 2020

- PMLiVE

Merck & Co’s Keytruda muscles further ahead of rivals in lung cancer

Granted accelerated review by FDA for use in combination with chemotherapy

FDA: Cybersecurity is an ever-present risk for medical devices

US regulator issues new guidance for manufacturers

Bayer symbol

Bayer nets speedy US review for regorafenib in liver cancer

Priority review in HCC boosts hopes for rejuvenation of Stivarga to combat declining sales

Biogen Idec building

FDA approves Biogen’s Spinraza for spinal muscular atrophy

Analysts predict blockbuster sales as drug is priced at $750,000 for first year of treatment

Alexion Pharmaceutiacal names interim CEO and CFO

Former AZ CEO David Brennan and David Anderson join

Roche Basel Switzerland

FDA delays verdict on Roche’s MS drug Ocrevus

Additional manufacturing data postpones US verdict until 28 March 2017

- PMLiVE

FDA okays Clovis’ Lynparza rival rucaparib

Analysts predict Rubraca could become a $1.5bn-plus product by 2020

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