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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

- PMLiVE

EMA set to review Teva’s migraine injection

Fremanezumab could be approved for prophylactic use of migraines

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

AstraZeneca AZ

AZ gets EMA green light for severe asthma drug Fasenra

The biologic respiratory treatment will go up against GSK’s Nucala and Teva’s Cinqaero

- PMLiVE

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

Rhopressa and Steglatro were among the final medicines licensed last year

- PMLiVE

Teva cuts 25% of workforce, with Israel taking a heavy toll

But share prices increase by almost 14%

- 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

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