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- PMLiVE

Viaskin Peanut

Bristol-Myers Squibb (BMS) building

BMS gets OK for monthly Opdivo dosing

Analysts predict the new dosing schedule could see the pharma giant win market share

Celgene building

FDA turns down Celgene’s filing for multiple sclerosis drug

The application needs additional pharmacology information according to the US agency

FDA approves AI-based decision support software

Viz.AI Contact alerts healthcare professionals if a patient is at risk of stroke

- 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

- 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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