Acuitive Technologies Receives FDA 510(k) Clearance for CITRELOCK DUO a New Sports Medicine Fixation Device for Biceps Tenodesis and Tendon Transfer Procedures
September 27, 2023 15:50 ET
|
Acuitive Technologies
ALLENDALE, N.J., September 27, 2023 -- Acuitive Technologies announced the FDA 510(k) Clearance of CITRELOCK DUO Fixation Device for biceps tenodesis
Theratechnologies Submits Tesamorelin F8 Formulation sBLA for FDA Review
September 25, 2023 07:00 ET
|
Theratechnologies
F8 formulation intended to replace EGRIFTA SV® with simplified dosing for the treatment of excess abdominal fat in adults with HIV and lipodystrophy MONTREAL, Sept. 25, 2023 (GLOBE NEWSWIRE) --...
Theratechnologies soumet un supplément à la licence de produit biologique (sBLA) pour la formulation F8 de la tésamoréline aux fins d’examen par la FDA
September 25, 2023 07:00 ET
|
Theratechnologies
La formulation F8 vise à remplacer EGRIFTA SV® par une posologie simplifiée pour le traitement de l’excès de graisse abdominale chez les adultes vivant avec le VIH atteints de lipodystrophie. ...
INTEGRA LIFESCIENCES INVESTOR ALERT: Kaplan Fox & Kilsheimer LLP Notifies Integra LifeSciences Investors of a Class Action Lawsuit and Upcoming Deadline
September 21, 2023 19:10 ET
|
Kaplan Fox & Kilsheimer LLP
NEW YORK, Sept. 21, 2023 (GLOBE NEWSWIRE) -- Kaplan Fox & Kilsheimer LLP reminds investors that a complaint has been filed on behalf of purchasers of investors that purchased or otherwise...
U.S. Food and Drug Administration Approves Orphan Drug Designation for Nexcella NXC-201 as a Treatment for Amyloid Light Chain (AL) Amyloidosis
September 21, 2023 09:05 ET
|
Nexcella, Inc.
FDA Orphan Drug Designation (“ODD”) qualifies one-time treatment NXC-201 for: 7 years of U.S. market exclusivity after approval Tax credits for qualified clinical testingWaiver of the Prescription...
U.S. Food and Drug Administration Approves Orphan Drug Designation for Immix Biopharma NXC-201 as a Treatment for Amyloid Light Chain (AL) Amyloidosis
September 21, 2023 08:55 ET
|
Immix Biopharma, Inc.
FDA Orphan Drug Designation (“ODD”) qualifies one-time treatment NXC-201 for: 7 years of U.S. market exclusivity after approval Tax credits for qualified clinical testingWaiver of the Prescription...
Silo Pharma Announces Positive Data on SPC-15 for PTSD and Prepares to File Pre-Investigational New Drug (IND) Application with FDA
September 20, 2023 08:28 ET
|
Silo Pharma, Inc.
Pre-IND submission to FDA targeted for first quarter 2024 Silo partners with Kymanox for SPC-15 ENGLEWOOD CLIFFS, NJ, Sept. 20, 2023 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq:...
60 Degrees Pharma Withdraws COVID Phase IIB IND, Will Resubmit Pending Assessment of Ability to Meet FDA Requirements
September 18, 2023 16:16 ET
|
Sixty Degrees Pharmaceuticals
Prompted by advice from FDA regarding study design, 60P Australia Pty Ltd, a majority-owned subsidiary of 60 Degrees Pharmaceuticals, has withdrawn its IND for ACLR8-LR, a Phase IIB study of the use...
Virios Therapeutics Announces Termination of At-The-Market Sales Agreement
September 18, 2023 07:05 ET
|
Virios Therapeutics
ATLANTA, Sept. 18, 2023 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology company focused on advancing novel antiviral therapies to...
Optimi Health Celebrates Encouraging Results from the MAPS Phase 3 MDMA-Assisted Therapy Clinical Trial
September 14, 2023 14:59 ET
|
Optimi Health Corp.
VANCOUVER, British Columbia, Sept. 14, 2023 (GLOBE NEWSWIRE) -- Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN), a Canadian psychedelics drug research and formulation company, is pleased...