Le Lézard
Classified in: Health
Subject: LICENSING AGREEMENTS

Theratechnologies Receives Update from FDA on Tesamorelin F8 Supplemental Biologic License Application


MONTREAL, Jan. 23, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, has received correspondence from the U.S. Food and Drug Administration (FDA) regarding the Company's supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin. The FDA has notified the Company that it is continuing its review of the application beyond the Prescription Drug User Fee Act (PDUFA) goal date of January 22, 2024.   Further information will be provided in due course.

About Theratechnologies

Theratechnologies (TSX: TH) (NASDAQ: THTX) is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs. Further information about Theratechnologies is available on the Company's website at www.theratech.com, on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Follow Theratechnologies on Linkedin and X (formerly Twitter). 

Contacts:

Media inquiries:
Julie Schneiderman
Senior Director, Communications & Corporate Affairs
[email protected]

Investor Inquiries:
Philippe Dubuc
Senior Vice President and Chief Financial Officer
[email protected]
438-315-6608

 



These press releases may also interest you

at 09:05
Smart Meter, the leading supplier of Cellular Remote Patient Monitoring (RPM)tm solutions, has introduced a new version of the iGlucose, its patented cellular-connected glucose meter used by over 200,000 people with diabetes since 2019. The...

at 09:00
Today, the Honourable Gary Anandasangaree, Minister of Crown-Indigenous Relations; the Honourable Patty Hajdu, Minister of Indigenous Services and Minister responsible for FedNor; the Honourable Dan Vandal, Minister of Northern Affairs; and the...

at 08:05
GE HealthCare today unveiled SIGNA MAGNUS, an FDA 510(k) pending head-only magnetic resonance (MR) scanner designed to explore advancements in neuroscience, which have been restricted by the performance limitations of conventional whole-body MR...

at 07:00
To mark National Hospice Palliative Care Week, the Quebec Coalition for Palliative Care Access (the Coalition) is proud to celebrate the positive impact of palliative care on the well-being of people with life-limiting illness. Palliative care is...

at 06:00
A native born and trained Brazilian oncologist is in the forefront of a new era in the treatment of cancer patients with cutting edge proton therapy medical technology developed in Israel by P-Cure. "It is my dream to be able to bring the P-Cure...

4 mai 2024
UroGen Pharma Ltd. , a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced results from a new analysis of the ATLAS trial, which estimates using Kaplan Meier...



News published on and distributed by: