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Bayer moves closer to US approval of PAH drug riociguat

FDA panel votes unanimously in favour of hypertension treatment

- PMLiVE

FDA panel turns down Otsuka’s drug for rare kidney disease

Unable to recommend expanded use of tolvaptan

- PMLiVE

GSK’s diabetes hope albiglutide delayed in US

FDA extends deadline to April 2014

Sanofi reception

FDA panel backs OTC use of Sanofi’s allergy drug

Says Nasacort AQ can be sold without prescription

Actelion HQ Switzerland

Actelion to buy Ceptaris – if FDA backs its cancer treatment

Acquisition contingent on Valchlor approval in rare lymphoma

FDA grants priority review to pain drug

Mallinckrodt’s MNK-795 is intended for the management of moderate to severe acute pain

- PMLiVE

AZ and BMS try again with Forxiga in the US

Pharma companies re-submit diabetes drug to the FDA for approval

- PMLiVE

FDA panel fails to back new use for AbbVie’s Humira

Votes 12 to 1 against new use in spondyloarthritis

Biogen Idec building

Biogen Idec’s long-acting beta interferon moves ahead in MS

US and EU accept filings for long-acting multiple sclerosis drug Plegridy

- PMLiVE

FDA approves intravenous Simponi for arthritis treatment

J&J says Simponi Aria will offer less frequent dosing schedule than subcutaneous version

- PMLiVE

FDA fast-tracks Elan’s Alzheimer’s drug

Speeds up regulatory process for ELND005 for the treatment of neuropsychiatric symptoms

- PMLiVE

FDA clears first brain test to diagnose ADHD in children

NEBA system available as part of wider clinical assessment

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