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Legal
Vanda Sues FDA Again, This Time Over Off-Label Use of Hetlioz for Jet Lag
Vanda is criticizing the FDA’s restrictions on information companies can provide regarding off-label use of approved medicines.
April 14, 2025
·
2 min read
·
Tristan Manalac
Pharm Country
Thubrikar Aortic Valve to Present Promising Initial Results of CE Mark-Enabling Study With Novel Optimum TAV™ at EuroPCR 2023
Thubrikar Aortic Valve, Inc., is happy to announce that results of the initial CE Mark-enabling study using the Optimum Transcatheter Aortic Valve (Optimum TAV™) in patients with severe aortic stenosis will be presented at the upcoming EuroPCR 2023 Conference.
May 2, 2023
·
3 min read
Press Releases
Averna Therapeutics, formerly known as Exsilio Therapeutics, Appoints Thomas M. Barnes, Ph.D., as Chief Executive Officer
January 27, 2025
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3 min read
Pharm Country
Thubrikar Aortic Valve completes initial CE Mark-enabling TAVI-1 Study
Thubrikar Aortic Valve, Inc., announced today that it has completed the initial CE Mark-enabling study using the Optimum Transcatheter Aortic Valve (Optimum TAV™) in patients with severe aortic stenosis.
October 21, 2022
·
3 min read
Breast cancer
AstraZeneca, Daiichi Sankyo’s ADC Wins First Approval Despite Mixed Data
Datroway, formerly known as Dato-DXd, significantly improved median progression-free survival in a Phase III study but failed to do so for overall survival.
January 21, 2025
·
2 min read
·
Tristan Manalac
Government
COVID-19 Critic Marty Makary Is Trump’s Likely Pick for FDA Top Post
Makary is a pancreatic surgeon at Johns Hopkins who became known for battling medical mistakes and in recent years has been an outspoken critic of COVID-19 policies.
November 21, 2024
·
2 min read
·
Tristan Manalac
IN PARTNERSHIP WITH ECLIPSEBIO
Beyond Black Box: How Data-Driven AI Is Transforming RNA Medicine Development
AI offers tremendous potential but there are critical and time-consuming flaws in black box AI predictions.
March 31, 2025
·
7 min read
·
BioSpace Insights
Press Releases
Celltrion’s Remdantry™, previously known as Inflectra®, will be available in Canada as of April 1, 2025
March 27, 2025
·
3 min read
Press Releases
ICU Medical Announces Time of First Quarter 2025 Earnings Conference Call
April 24, 2025
·
1 min read
Bio NC
Marken Opens Two New GMP Depots
Marken announced the launch of two new facilities in Kiev, Ukraine and in Los Angeles, United States.
December 22, 2020
·
2 min read
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