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- PMLiVE

buprenorphine

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

Health coverage across state lines

Despite a total lack of legislative wins, the new administration has made its presence felt at home and abroad

- 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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