In new draft guidance, the FDA has taken steps to eliminate the clinical testing of biosimilars and to categorize all ...

A myasthenia gravis treatment revolution has taken place in the past four years, spurred by an initial approval for argenx’s ...

After a progression-free survival win last year raised hopes for the combo's potential in hepatocellular carcinoma, an overall survival miss brings the study to a close.

Akebia Therapeutics has scrapped plans for trial that would have potentially led to an expansion of the patient population for its new anemia drug Vafseo, the company said.

Emma Walmsley and her GSK CEO successor, Luke Miels, are safeguarding the British pharma’s 40-billion-pound sales projection ...

Picking a date for a press conference in Puerto Rico in the middle of hurricane season can be risky business. | Eli Lilly has ...

With a physician mother and geologist father, Katie Morris, Ph.D., was immersed in the world of science from a young age. | ...

As Merck looks for growth opportunities ahead of Keytruda’s tumble over the patent cliff, the company’s future now looks a ...

The FDA has issued another complete response letter (CRL) to Regeneron, rejecting its bid for approval of its prefilled syringe version of high-dose (HD) Eylea—again for unresolved issues at the ...

Shortly after taking reins at BioMarin, CEO Alexander Hardy laid out three paths the company could take for its struggling ...

Novartis has started to feel the squeeze from generics to its top-selling drug, heart therapy Entresto. | Novartis has ...

The FDA has slammed generic drug maker Hetero Labs with a Form 483 after an inspection of one of its warehouses in India ...