Pharmafile Logo

TNBC

- PMLiVE

FDA won’t add outcomes data to Januvia label

Merck & Co’s application rejected despite TECOS outcomes data

- PMLiVE

FDA changes its mind on 23andMe’s genetic testing kits

Approves a home test kit for gene sequences related to diseases like Alzheimer’s and Parkinson’s

- PMLiVE

AbbVie and J&J file first non-cancer use for Imbruvica with FDA

Seeks FDA approval to treat GVHD patients

- PMLiVE

BMS closes in on colorectal cancer indication for Opdivo

Gains US priority review to treat patients with dMMR or MSI-H colorectal cancer

- PMLiVE

FDA approves Teva’s Huntington’s disease drug at second attempt

Austedo will treat fatal degenerative disorder chorea

- PMLiVE

Novartis gets lung cancer OK for Tafinlar/Mekinist combo

It can now be used to treat BRAF V600E-positive NSCLC patients in Europe

Novartis day

Novartis files CAR-T therapy in US, with swift review

CTL109 candidate gets FDA priority review status

- PMLiVE

Tesaro joins PARP parade with US approval of Zejula

Unlike its rivals Zejula doesn’t require a BRCA mutation in patients before use

- PMLiVE

Keytruda and Opdivo backed for new uses in Europe

CHMP recommendations also include Trumenba, Dinutuximab beta and Refixia

- PMLiVE

Merck, Pfizer get first OK for checkpoint inhibitor avelumab

FDA approval for rare skin cancer drug

AstraZeneca AZ

FDA turns down AZ’s ZS-9 once again on manufacturing issues

The regulator says it can resubmit the application once deficiencies are tackled

- PMLiVE

Keytruda claims first blood cancer OK from FDA

Merck & Co wins US approval for its haematological cancer treatment

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links