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- PMLiVE

FDA ‘must publish biosimilar naming guide soon’

US politicians push regulator to finalise guidance

- PMLiVE

AstraZeneca signs $2bn deal to buy Almirall respiratory portfolio

Will boost its pipeline prospects and inhaled device capabilities

- PMLiVE

J&J’s Imbruvica wins new cancer indication

FDA backs drug’s use in chronic lymphocytic leukaemia patients with genetic mutation

- PMLiVE

FDA approves pain drug that has reduced risk of abuse

Purdue’s Targiniq ER developed to deter snorting and injection

- PMLiVE

Neupogen will be first biologic on FDA biosimilars pathway

US regulator will review Novartis’  version of Amgen's Neupogen (filgrastim) over the coming months

- PMLiVE

FDA approves Gilead drug in three blood cancers

Zydelig recommended for use in chronic lymphocytic leukaemia and two forms of lymphoma

- PMLiVE

BMJ accuses Boehringer of withholding Pradaxa data

Claims current FDA recommendation for anticoagulant may be flawed

- PMLiVE

FDA approves drug for rare swelling diseases

Salix and Pharming’s Ruconest is made from the milk of genetically-modified rabbits

- PMLiVE

GSK trial throws everything at COPD

Tests combination of fluticasone furoate, umeclidinium and vilanterol

- PMLiVE

Priority review for Roche’s Avastin in cervical cancer

Will speed up FDA assessment of oncology drug

- PMLiVE

Otsuka and Lundbeck file Abilify follow-up in the US

Brexpiprazole to be reviewed for use in schizophrenia and major depressive disorder

- PMLiVE

Sun Pharma recalls antidepressant in US

Withdraws more than 40,000 bottles of venlafaxine hydrochloride

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