Another billion-dollar-plus deal failed to play out as planned as the FDA dealt Teva Pharmaceutical Industries Ltd. a complete response letter (CRL) on its new drug application (NDA) for SD-809 ...
On Thursday, Telix Pharmaceuticals Limited (NASDAQ:TLX) received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) for ...
Replimune Group, Inc. received a surprising FDA Complete Response Letter for RP1, citing inadequate trial design and concerns over data interpretation. RP1's delayed approval and the need for a new ...
Shares of Outlook Therapeutics OTLK tumbled 54.1% after the FDA issued a second complete response letter (CRL) rejecting its biologics license application (BLA) resubmission for ONS-5010 in wet ...
The FDA's policy of publishing CRLs aims to enhance transparency and accelerate drug development by providing early access to regulatory feedback. The release of CRLs has elicited mixed reactions, ...
The saliva-based CRL Rapid Response Test is focused on getting businesses and schools back to work. Clinical Reference Laboratories CEO Robert Thompson joins Jill Malandrino on Nasdaq #TradeTalks to ...
However, Capricor rebuts this claim, noting that the primary endpoint data was analysed with a non-parametric test – meaning it needed transforming to reach a statistically significant p value of ...
New York City, Aug. 05, 2020 (GLOBE NEWSWIRE) -- Saliva-Based Test Powered by Co-Diagnostics (NASDAQ:CODX) a Game Changer Maxim reiterate Buy with a price target of $30 Earlier this week, ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback