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DNLI's Hunter Syndrome Drug Gets Breakthrough Therapy Designation
Denali Therapeutics Inc. DNLI announced that the FDA has granted Breakthrough Therapy Designation to its pipeline candidate, tividenofusp alfa (DNL310), for the treatment of individuals with Hunter ...
infectiousdiseaseadvisor.com3d
Brelovitug Granted Breakthrough Designation for Chronic Hepatitis Delta
The FDA has granted Breakthrough Therapy designation to brelovitug (BJT-778) for the treatment of chronic hepatitis delta.
Healio7d
Bluejay Therapeutics’ brelovitug secures FDA breakthrough status for chronic HDV
Please provide your email address to receive an email when new articles are posted on . The FDA has granted breakthrough therapy designation to Bluejay Therapeutics’ brelovitug for the treatment ...
Morningstar6d
IntelliGenome Receives FDA Breakthrough Device Designation for CRISPR-TB Blood Test
"The FDA's Breakthrough Device Designation for our CRISPR-TB Blood Test is a significant milestone for IntelliGenome. This recognition highlights our commitment to advancing innovative, accessible ...
Business Insider20d
Rezolute Gains FDA Breakthrough Designation for Ersodetug
Rezolute, Inc. announced that the FDA has granted Breakthrough Therapy Designation to its drug, ersodetug, for treating hypoglycemia caused by congenital hyperinsulinism. This designation ...
SiliconRepublic8d
CergenX making Waves with new FDA designation
Now, with its latest achievements, CergenX plans to collaborate with the FDA throughout the Wave device’s development and premarket review. “Receiving the Breakthrough Device Designation and ...
medtechdive6d
Irish Neurotech Start-up, CergenX Receives FDA Breakthrough Designation for Wave Device
A CergenX-led consortium, including UCC/ INFANT, was awarded €6.7 million in funding from The Disruptive Technologies ...
Business Insider20d
Rezolute Receives Breakthrough Therapy Designation from FDA for Ersodetug in the Treatment of Hypoglycemia Due to Congenital Hyperinsulinism
These forward-looking statements include but are not limited to statements regarding the FDA’s grant of the Breakthrough Therapy Designation for ersodetug, the ersodetug Expanded Access Program ...
Nasdaq18d
DNLI's Hunter Syndrome Drug Gets Breakthrough Therapy Designation
Breakthrough Therapy Designation is generally granted to ... This designation will provide Denali with more intensive FDA guidance, including involvement of senior reviewers, and eligibility ...