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- 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

- PMLiVE

Amgen’s chronic kidney disease drug Parsabiv cleared in US

Sensipar follow-up is the first therapy to be approved for treatment of sHPT in 12 years

- PMLiVE

Cellectis gets FDA nod for ‘off-the-shelf’ CAR-T trial

Investigational New Drug gets go-ahead for trials in patients with two haematological cancers

- PMLiVE

Keytruda filed for first- and second-line bladder cancer

Merck & Co hopes to gain advantage over Opdivo and Tecentriq with first-line setting

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