Pharmafile Logo
T40 2022 Cover
Diversity, Equity and Inclusion
Communiqué 53 Cover Image
- PMLiVE

Janet Woodcock

- 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

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

- PMLiVE

FDA sets out framework for rare childhood diseases

Wants to encourage more trial use of biomarkers and speedier approval timelines

- PMLiVE

FDA to review Sanofi’s Lantus successor

Decision on company’s next generation insulin Toujeo expected early next year

- PMLiVE

Amgen and Boehringer drugs win FDA breakthrough status

Leukaemia drug and Pradaxa antidote will benefit from accelerated regulatory processes

- PMLiVE

Third time lucky as MannKind’s inhaled insulin is approved

US FDA backs new diabetes treatment Afrezza

- PMLiVE

AZ needs more data on olaparib, says FDA panel

Agency advisers demands more safety information on ovarian cancer drug

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links