In the CRL, the Agency concluded that the NDA could not be accepted due to issues that are inherent to real-world evidence and external control studies. The Food and Drug Administration (FDA) has ...
A recent study of clinical and genetic characteristics in patients with hereditary spastic paraplegia highlights the difficulties of making clinicogenetic correlations in a heterogeneous group of ...
Spinocerebellar ataxia type 1 (SCA1) is an inherited neurodegenerative disease involving progressive loss of motor and cognitive function resulting from the death of cerebellar neurons. Watase et al.
Biohaven (BHVN) has been downgraded to Market-Perform from Outperform at Bernstein, following the U.S. FDA’s complete response letter for troriluzole in spinocerebellar ataxia. The firm described the ...
Shares of Biohaven (BHVN) plunged ~44% in the premarket on Wednesday after the company said the U.S. FDA issued a Complete Response Letter in response to its marketing application for its lead asset ...
Will Kenton is an expert on the economy and investing laws and regulations. He previously held senior editorial roles at Investopedia and Kapitall Wire and holds a MA in Economics from The New School ...
After getting a green light from the European Commission, Biogen’s Skyclarys is the first approved medicine for the inherited neurological disease Friedreich’s ataxia (FA) in the EU. Skyclarys ...
Brian Beers is a digital editor, writer, Emmy-nominated producer, and content expert with 15+ years of experience writing about corporate finance & accounting, fundamental analysis, and investing.
You can practice progressive muscle relaxation to relieve throat tension and make swallowing easier. Try diaphragmatic breathing to relax your throat muscles and ease swallowing difficulties.
Indicator species are living organisms that tell us that something has changed or is going to change in their environment. They can be easily observed, and studying them is considered a cost-effective ...
Oral sex with a skilled partner is one part of sex that is absolutely worth the hype. If you’re receiving, we’re talking mind-blowing orgasms and incredible intimacy. And if you’re giving? Get ready ...