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- PMLiVE

J&J’s Erleada first US drug for non-metastatic prostate cancer

Drug approved by the FDA on the back of data from the SPARTAN study

- PMLiVE

Smart watch epilepsy monitor cleared by FDA

Approval could potentially clear the way for insurers to reimburse its cost

dengue fever mosquito

Takeda gets FDA fast-track status for Zika vaccine

The phase I candidate also has the backing of US federal funding body BARDA

- PMLiVE

Novartis gets speedy reviews for new Kymriah filings

US and EU regulatory agencies will review the drug for DLBCL patients

- PMLiVE

AZ and Merck & Co get FDA breast cancer nod for Lynparza

It becomes the first PARP inhibitor to be approved outside ovarian cancer

- PMLiVE

FDA’s year-end approvals take annual tally to 46

Rhopressa and Steglatro were among the final medicines licensed last year

AVEO appoints Nikhil Mehta as its senior VP, regulatory and quality assurance

He joins the biopharma from Tang Capital Management

- PMLiVE

Novo Nordisk gets FDA nod for once-weekly rival to Lilly’s Trulicity

GLP-1 agonist Ozempic approved in the US for type 2 diabetes

- PMLiVE

Mylan gets first biosimilar Herceptin OK from FDA

Ogivri approved by US regulators for all of Roche blockbuster's indications

- PMLiVE

FDA approves first Apple Watch medical device accessory

Kardia Band functions as a real-time electrocardiogram

AstraZeneca AZ

Setback for AZ as tralokinumab flunks asthma trial

Puts more pressure on AZ’s benralizumab to reach its potential

- PMLiVE

AZ gets early FDA green light for Imbruvica challenger

Sets up a marketing battle with Johnson/AbbVie

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