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- PMLiVE

Intellipharmaceutics

- PMLiVE

New FDA guidance for advertising

Clarifies circumstances when drug names need to be mentioned

- 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

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

UCB files Vimpat for expanded epilepsy use

Submits monotherapy application to FDA


- 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

Novartis building

Novartis weighs in on biosimilar naming debate

Files petition urging FDA to keep system where biosimilars share a name with the original drug

- PMLiVE

FDA raises awareness of misleading drug ads

E-learning course to help HCPS and students learn how to report untruthful promotion

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