Keeping Track: Personalized Medicine For Lung Cancer Evolves; Idelvion Is CBER's First Novel Approval In 2016
The latest drug development news and highlights from our FDA Performance Tracker.
You may also be interested in...
Bromday Larger Bottle Gets Wink From Advisory Cmte. Still Torn On Safety
FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee said there are good reasons for FDA to approve larger fill sizes for Ista’s ocular anti-inflammatory drops, although there isn’t enough evidence to say using them in both eyes would be safe.
Big Pharma Companies Have Higher US FDA Approval Percentage Than Everybody Else
Almost 80% of novel agent submissions from the biggest companies were approved in recent years, compared with a 60% approval rate for the rest of the industry, according to a Pink Sheet analysis of FDA approval decisions since 2021.
US FDA Complete Response Letter Rates Vary With Sponsor Size
Pink Sheet infographic illustrates benefits of big pharma’s resources and experience.