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

tolvaptan

- PMLiVE

Tesaro joins PARP parade with US approval of Zejula

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

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

Novartis day

FDA approval for Kisqali sets up showdown with Ibrance

Novartis breast cancer therapy drug has been predicted to reach blockbuster status

- PMLiVE

Trump nominates Gottlieb to head FDA

If confirmed he would take over from previous commissioner Robert Califf

Sanofi reception

Sanofi adds to dupilumab evidence base as US approval nears

FDA to deliver verdict on atopic dermatitis drug

- PMLiVE

Move on Immunomedics board puts Seattle Genetics deal in doubt

Four venBio candidates voted to the board which gives group a majority

- PMLiVE

FDA sets August review date for Teva’s movement disorder drug

Could be first approved treatment for tardive dyskinesia

- PMLiVE

AZ gets US approval for diabetes combo Qtern

Wins licensing for Onglyza/Farxiga dual-therapy after rejection by the FDA in 2015

- PMLiVE

Novartis’ Zykadia nears first-line lung cancer label

Hopes to boost slow second-line sales to compete directly with Pfizer’s Xalkori and Roche’s Alecensa 

- PMLiVE

FDA verdict on Pfizer’s breakthrough leukaemia drug due in August

Phase III trials results saw complete remission in 81% of patients in the treatment group

- PMLiVE

FDA OKs Valeant’s psoriasis drug Siliq, with black box warning

Suicidal ideation labelling adds to challenge in rivalling Novartis’ Cosentyx and Lilly’s Taltz

- PMLiVE

FDA approves first steroid for Duchenne muscular dystrophy

Marathon Pharma’s Emflaza is first approved to treat all genetic forms of the condition

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links