* . *
  • About
  • Advertise
  • Privacy & Policy
  • Contact
Sunday, May 18, 2025
Earth-News
  • Home
  • Business
  • Entertainment

    Nile Entertainment Secures African Rights for Thrilling Action Film ‘Son of the Soil

    Florida Highwaymen movie ‘Legends of the Highway’ based on original 26 Black artists – Treasure Coast News

    Unveiling ‘Legends of the Highway’: A Captivating Film Celebrating the Legacy of Florida’s Original 26 Black Artists

    Alabama to expand Entertainment Industry Incentive Act – WVTM

    Alabama Boosts Entertainment Industry with Expanded Incentive Act!

    Toast Sets Its Sights on Revolutionizing Entertainment Venues

    Eva Dickerman Joins Entertainment 360 As Partner – Deadline

    Eva Dickerman Takes the Spotlight as New Partner at Entertainment 360!

    Avid Appoints Act Entertainment as U.S. Distributor for Its Live Sound Portfolio – TVTechnology

    Avid Teams Up with Act Entertainment to Bring Live Sound Innovations to the U.S. Market!

  • General
  • Health
  • News

    Cracking the Code: Why China’s Economic Challenges Aren’t Shaking Markets, Unlike America’s” – Bloomberg

    Trump’s Narrow Window to Spread the Truth About Harris

    Trump’s Narrow Window to Spread the Truth About Harris

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Trending Tags

    • Trump Inauguration
    • United Stated
    • White House
    • Market Stories
    • Election Results
  • Science
  • Sports
  • Technology
    Super Speeders are deadly. This technology can slow them down. – Popular Science

    Revolutionary Technology: Taming the Threat of Super Speeders!

    Celebrating Success: Highlights from the Collaborative College for Technology & Leadership Graduation Ceremony

    Philly police unveil strategy to crack down on car meetups utilizing technology – NBC10 Philadelphia

    Philly Police Launch High-Tech Strategy to Tackle Car Meetups!

    Stony Brook Medicine Pioneers Use of AI Technology for Heart Disease Diagnosis on Long Island – SBU News

    Revolutionizing Heart Health: Stony Brook Medicine Leads the Way with AI Technology

    How to Clean Up and Restore Low-Quality Videos with AI Technology – finehomesandliving.com

    How to Clean Up and Restore Low-Quality Videos with AI Technology – finehomesandliving.com

    Opening kids’ eyes to the wonders of Information and Communication Technology at EBU Girls in ICT Day 2025 – EBU tech

    Unleashing Curiosity: Exploring the Magic of Information and Communication Technology at EBU Girls in ICT Day 2025!

    Trending Tags

    • Nintendo Switch
    • CES 2017
    • Playstation 4 Pro
    • Mark Zuckerberg
No Result
View All Result
  • Home
  • Business
  • Entertainment

    Nile Entertainment Secures African Rights for Thrilling Action Film ‘Son of the Soil

    Florida Highwaymen movie ‘Legends of the Highway’ based on original 26 Black artists – Treasure Coast News

    Unveiling ‘Legends of the Highway’: A Captivating Film Celebrating the Legacy of Florida’s Original 26 Black Artists

    Alabama to expand Entertainment Industry Incentive Act – WVTM

    Alabama Boosts Entertainment Industry with Expanded Incentive Act!

    Toast Sets Its Sights on Revolutionizing Entertainment Venues

    Eva Dickerman Joins Entertainment 360 As Partner – Deadline

    Eva Dickerman Takes the Spotlight as New Partner at Entertainment 360!

    Avid Appoints Act Entertainment as U.S. Distributor for Its Live Sound Portfolio – TVTechnology

    Avid Teams Up with Act Entertainment to Bring Live Sound Innovations to the U.S. Market!

  • General
  • Health
  • News

    Cracking the Code: Why China’s Economic Challenges Aren’t Shaking Markets, Unlike America’s” – Bloomberg

    Trump’s Narrow Window to Spread the Truth About Harris

    Trump’s Narrow Window to Spread the Truth About Harris

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Trending Tags

    • Trump Inauguration
    • United Stated
    • White House
    • Market Stories
    • Election Results
  • Science
  • Sports
  • Technology
    Super Speeders are deadly. This technology can slow them down. – Popular Science

    Revolutionary Technology: Taming the Threat of Super Speeders!

    Celebrating Success: Highlights from the Collaborative College for Technology & Leadership Graduation Ceremony

    Philly police unveil strategy to crack down on car meetups utilizing technology – NBC10 Philadelphia

    Philly Police Launch High-Tech Strategy to Tackle Car Meetups!

    Stony Brook Medicine Pioneers Use of AI Technology for Heart Disease Diagnosis on Long Island – SBU News

    Revolutionizing Heart Health: Stony Brook Medicine Leads the Way with AI Technology

    How to Clean Up and Restore Low-Quality Videos with AI Technology – finehomesandliving.com

    How to Clean Up and Restore Low-Quality Videos with AI Technology – finehomesandliving.com

    Opening kids’ eyes to the wonders of Information and Communication Technology at EBU Girls in ICT Day 2025 – EBU tech

    Unleashing Curiosity: Exploring the Magic of Information and Communication Technology at EBU Girls in ICT Day 2025!

    Trending Tags

    • Nintendo Switch
    • CES 2017
    • Playstation 4 Pro
    • Mark Zuckerberg
No Result
View All Result
Earth-News
No Result
View All Result
Home Business

Theratechnologies Receives January 2024 PDUFA Goal Date for Tesamorelin F8 Formulation sBLA

October 4, 2023
in Business
Theratechnologies Receives January 2024 PDUFA Goal Date for Tesamorelin F8 Formulation sBLA
Share on FacebookShare on Twitter

Author of the article:

GlobeNewswire

Published Oct 04, 2023  •  4 minute read

This news release constitutes a “designated news release” for the purposes of the Company’s prospectus supplement dated December 16, 2021 to its short form base shelf prospectus dated December 14, 2021.

MONTREAL, Oct. 04, 2023 (GLOBE NEWSWIRE) — Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that the U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) goal date of January 22, 2024 to the Company’s supplemental Biologics License Application (sBLA) of the F8 formulation of tesamorelin.

Advertisement 2

This advertisement has not loaded yet, but your article continues below.

Financial Post

THIS CONTENT IS RESERVED FOR SUBSCRIBERS ONLY

Subscribe now to read the latest news in your city and across Canada.

Exclusive articles by Kevin Carmichael, Victoria Wells, Jake Edmiston, Gabriel Friedman and others.Daily content from Financial Times, the world’s leading global business publication.Unlimited online access to read articles from Financial Post, National Post and 15 news sites across Canada with one account.National Post ePaper, an electronic replica of the print edition to view on any device, share and comment on.Daily puzzles, including the New York Times Crossword.

SUBSCRIBE TO UNLOCK MORE ARTICLES

Subscribe now to read the latest news in your city and across Canada.

Exclusive articles by Kevin Carmichael, Victoria Wells, Jake Edmiston, Gabriel Friedman and others.Daily content from Financial Times, the world’s leading global business publication.Unlimited online access to read articles from Financial Post, National Post and 15 news sites across Canada with one account.National Post ePaper, an electronic replica of the print edition to view on any device, share and comment on.Daily puzzles, including the New York Times Crossword.

REGISTER TO UNLOCK MORE ARTICLES

Create an account or sign in to continue with your reading experience.

Access articles from across Canada with one account.Share your thoughts and join the conversation in the comments.Enjoy additional articles per month.Get email updates from your favourite authors.

Article content

Article content

Tesamorelin is the only medication approved in the U.S. for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy. Once approved, the F8 formulation is set to replace the current F4 formulation, which is sold in the U.S. under the trade name EGRIFTA SV®. The proposed proprietary name for the F8 formulation of tesamorelin, EGRIFTA MDVTM, is already under review by the FDA.

In accordance with the FDA’s standard review practices, unless the Company is notified before November 21, 2023, that the application is not sufficiently complete to permit a substantive review, the FDA will file the sBLA for the F8 formulation of tesamorelin.

About EGRIFTA SV®
(tesamorelin for injection)

EGRIFTA SV® is approved in the U.S. for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy*. EGRIFTA SV® is a growth hormone releasing factor (GHRF) analog that acts on pituitary cells in the brain to stimulate the production and release of endogenous growth hormone.

* Limitations of Use:

Long-term cardiovascular safety of EGRIFTA SV® has not been established. Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue. EGRIFTA SV® is not indicated for weight loss management as it has a weight neutral effect. There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA SV®.

By signing up you consent to receive the above newsletter from Postmedia Network Inc.

Article content

Advertisement 3

This advertisement has not loaded yet, but your article continues below.

Article content

Do not use EGRIFTA SV® if a patient:

Has a pituitary gland tumor, has had pituitary gland surgery, has other problems related to their pituitary gland, or has had radiation treatment to their head or head trauma. Has active cancer. Is allergic to tesamorelin or any of the ingredients in EGRIFTA SV®. Is pregnant or planning to become pregnant.

The most commonly reported adverse reactions of EGRIFTA SV® include: hypersensitivity reactions, hyperglycemia, injection site reactions, arthralgia, pain in extremity, myalgia and peripheral edema.

Refer to www.egriftasv.com for the full prescribing information, patient information and instructions for use for further details about this product.

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 Twitter.

Advertisement 4

This advertisement has not loaded yet, but your article continues below.

Article content

Forward-Looking Information

This press release contains forward-looking statements and forward-looking information (collectively, the “Forward-Looking Statements”), within the meaning of applicable securities laws, that are based on our management’s beliefs and assumptions and on information currently available to our management. You can identify Forward-Looking Statements by terms such as “may”, “will”, “should”, “could”, “promising”, “would”, “outlook”, “believe”, “plan”, “envisage”, “anticipate”, “expect” and “estimate”, or the negatives of these terms, or variations of them. The Forward-Looking Statements contained in this press release include, but are not limited to, statements regarding the approval and filing of the F8 formulation by the FDA and its proposed trade name, EGRIFTA MDVTM, and the exact user fee goal date. Although the Forward-Looking Statements contained in this press release are based upon what the Company believes are reasonable assumptions in light of the information currently available, investors are cautioned against placing undue reliance on this information since actual results may vary from the Forward-Looking Statements. Certain assumptions made in preparing the Forward-Looking Statements include that: the FDA will file the F8 formulation the user fee goal date will remain on January 22, 2024. Forward-Looking Statements are subject to a number of risks and uncertainties, many of which are beyond Theratechnologies’ control that could cause actual results to differ materially from those that are disclosed in or implied by such Forward-Looking Statements. These risks and uncertainties include, but are not limited to, those related to or arising from: a delay in the filing of the sBLA for the F8 formulation, the postponement of the user fee goal date, a rejection of the sBLA by the FDA because it deems that the submission does not contain all of the prescribed information, and the non-approval of the F8 formulation by the FDA preventing its commercial launch in the United States. We refer current and potential investors to the “Risk Factors” section of our Annual Information Form dated February 27, 2023, available on SEDAR at www.sedarplus.ca and on EDGAR at www.sec.gov as an exhibit to our report on Form 40-F dated February 28, 2023, under Theratechnologies’ public filings for additional risks involved in our business. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on Forward-Looking Statements. Forward-Looking Statements reflect current expectations regarding future events and speak only as of the date of this press release and represent our expectations as of that date. We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.

Contacts:

Media inquiries:
Julie Schneiderman
Senior Director, Communications & Corporate Affairs
communications@theratech.com
514-336-7800

Investor Inquiries:
Philippe Dubuc
Senior Vice President and Chief Financial Officer
pdubuc@theratech.com
438-315-6608

Article content

>>> Read full article>>>
Copyright for syndicated content belongs to the linked Source : Financial Post – https://financialpost.com/globe-newswire/theratechnologies-receives-january-2024-pdufa-goal-date-for-tesamorelin-f8-formulation-sbla

Tags: businessReceivesTheratechnologies
Previous Post

American Pacific Announces Regional Exploration Drilling to Build on Successful 2023 Field Season at The Palmer VMS Project

Next Post

QuantGate Systems Inc. Signs Collaboration Agreement with Oxford Immune Algorithmics (OIA), Welcomes AI Expert Dr. Hector Zenil to Advisory Board

Apex mayor lead 1,000 men in march for mental health awareness – WRAL.com

Apex mayor lead 1,000 men in march for mental health awareness – WRAL.com

May 18, 2025
Far-right leaders attempting to hijack success of Reform – BBC

Far-Right Leaders Seek to Capitalize on Reform’s Momentum

May 18, 2025
Super Speeders are deadly. This technology can slow them down. – Popular Science

Revolutionary Technology: Taming the Threat of Super Speeders!

May 18, 2025
USMNT’s Richards, Turner are FA Cup champs as Crystal Palace beats City – FOX Sports

USMNT Stars Richards and Turner Celebrate FA Cup Victory as Crystal Palace Triumphs Over City!

May 18, 2025
‘This should not be published’: Scientists cast doubt on study claiming trees ‘talk’ before solar eclipses – Live Science

Are Trees Really ‘Talking’ Before Solar Eclipses? Scientists Raise Doubts About Controversial Study

May 18, 2025
Doctor’s Diary: I Couldn’t Put Plato’s Revenge Down – Evolution News

Unraveling the Intrigue: Why Plato’s Revenge Captivated My Mind

May 18, 2025
Arthritis Awareness Month: Manage symptoms with treatment and lifestyle changes – KRQE

Arthritis Awareness Month: Manage symptoms with treatment and lifestyle changes – KRQE

May 18, 2025
Seventy-eighth World Health Assembly – World Health Organization (WHO)

Highlights and Key Takeaways from the 78th World Health Assembly

May 18, 2025
Visitors to Georgia’s artificial reef contributed $8.2M to coastal economy in 2023, study says – Now Habersham

Visitors to Georgia’s artificial reef contributed $8.2M to coastal economy in 2023, study says – Now Habersham

May 18, 2025

Nile Entertainment Secures African Rights for Thrilling Action Film ‘Son of the Soil

May 18, 2025

Categories

Archives

May 2025
MTWTFSS
 1234
567891011
12131415161718
19202122232425
262728293031 
« Apr    
Earth-News.info

The Earth News is an independent English-language daily published Website from all around the World News

Browse by Category

  • Business (20,132)
  • Ecology (616)
  • Economy (629)
  • Entertainment (21,543)
  • General (15,223)
  • Health (9,672)
  • Lifestyle (634)
  • News (22,149)
  • People (633)
  • Politics (638)
  • Science (15,853)
  • Sports (21,140)
  • Technology (15,621)
  • World (619)

Recent News

Apex mayor lead 1,000 men in march for mental health awareness – WRAL.com

Apex mayor lead 1,000 men in march for mental health awareness – WRAL.com

May 18, 2025
Far-right leaders attempting to hijack success of Reform – BBC

Far-Right Leaders Seek to Capitalize on Reform’s Momentum

May 18, 2025
  • About
  • Advertise
  • Privacy & Policy
  • Contact

© 2023 earth-news.info

No Result
View All Result

© 2023 earth-news.info

No Result
View All Result

© 2023 earth-news.info

Go to mobile version