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- PMLiVE

FDA turns down Forest/Gedeon Richter’s antipsychotic

US regulator wants more information for cariprazine

- PMLiVE

AZ drug for opioid constipation starts FDA review

Naloxegol on course to compete with Takeda’s Amitiza

- PMLiVE

Teva withdraws US filing for cancer biologic

FDA requests more data for balugrastim

- PMLiVE

MedImmune appoints head of research

Yong-Jun Liu to lead R&D at AstraZeneca biologics subsidiary

- PMLiVE

FDA clears J&J’s breakthrough lymphoma therapy

Imbruvica approved to treat mantle cell lymphoma

- PMLiVE

Sarepta slumps as FDA questions muscular dystrophy drug

US regulator casts doubt on biomarker for eteplirsen

- PMLiVE

AZ invests £120m in UK cancer drug production

New facility in Macclesfield to manufacture Zoladex will retain 300 jobs

- PMLiVE

UCB files Vimpat for expanded epilepsy use

Submits monotherapy application to FDA


- PMLiVE

AZ strikes antibiotic deal with Singapore research unit

Deal with A*STAR to tackle antimicrobial resistance

- PMLiVE

FDA clears Roche’s breakthrough drug Gazyva

First drug approved in US under new scheme

- PMLiVE

FDA suspends sale of Ariad’s cancer drug

Iclusig linked to increased risk of blood clots

- PMLiVE

FDA creates drug shortage plan

Manufacturers required to give early notice of potential shortfall of important medicines

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