FDA Approval
Cingulate Advances ADHD Treatment Toward 2026 FDA Decision with Key Milestones
Cingulate Inc. progresses toward potential 2026 commercial launch of its ADHD treatment CTx-1301 following FDA acceptance of its New Drug Application and positive pediatric trial results, addressing a large market with unmet needs.
HeartBeam's Cable-Free ECG Technology Poised to Transform Cardiac Care Delivery
HeartBeam's FDA-pending portable 12-lead ECG technology could revolutionize cardiac diagnostics by enabling clinical-grade monitoring outside medical facilities, potentially reducing healthcare burdens and improving access in underserved areas.
HeartBeam Advances Revolutionary ECG Technology Toward FDA Clearance and Commercial Launch
HeartBeam Inc. is preparing for the commercial launch of its innovative 12-lead ECG synthesis software for arrhythmia assessment, which could transform cardiac diagnostics in both clinical and home settings pending FDA clearance expected by year-end.
Nutriband Reports 51% Revenue Growth, Advances Abuse-Deterrent Fentanyl Patch Toward FDA Approval
Nutriband Inc. achieved significant revenue growth and strengthened its financial position to advance AVERSA Fentanyl, potentially becoming the first global abuse-deterrent transdermal fentanyl product with estimated peak annual sales of $80-200 million.
Nutriband Advances AVERSA™ Fentanyl Patch Toward FDA Submission with Scaled Manufacturing
Nutriband Inc. has scaled manufacturing for its abuse-deterrent fentanyl patch AVERSA™ through collaboration with Kindeva, positioning the company for FDA submission and potential global commercialization with established patent protection across multiple regions.
Nutriband Secures $5.3 Million Through Warrant Exercises to Advance Abuse-Deterrent Fentanyl Patch Development
Nutriband Inc. has raised $5.3 million from warrant exercises to fund the clinical development and FDA submission of AVERSA Fentanyl, potentially the world's first abuse-deterrent opioid patch with estimated peak annual U.S. sales of $80-200 million.
HeartBeam Inc. Advances Toward FDA Clearance with Promising Q2 2025 Results
HeartBeam Inc. reports significant progress toward FDA clearance for its innovative 12-lead ECG synthesis software, highlighting its potential to revolutionize cardiac care outside medical facilities.
Nutriband Inc. CEO Temporarily Steps Down to Pursue Irish Presidency, Company Focuses on AVERSA Fentanyl Development
Nutriband Inc. announces CEO Gareth Sheridan's temporary departure to run for Irish Presidency, with Chairman Serguei Melnik stepping in, as the company advances its AVERSA Fentanyl abuse-deterrent opioid patch towards FDA approval.
Nutriband Inc. Advances Toward FDA Approval for AVERSA(TM) Fentanyl Abuse-Deterrent Patch
Nutriband Inc. has secured a Type C Meeting with the FDA for its AVERSA(TM) Fentanyl patch, a significant step towards introducing the world's first abuse-deterrent opioid patch to the market.
Nutriband Inc. Ties Shareholder Rewards to FDA Approval Milestone with 25% Preferred Stock Dividend
Nutriband Inc. (NASDAQ: NTRB) has announced a 25% preferred stock dividend, linking shareholder rewards directly to the FDA approval process for its lead product, AVERSA(TM) Fentanyl, highlighting the significance of regulatory achievements in biopharmaceutical value creation.
Tonix Pharmaceuticals Added to Russell 3000 and 2000 Indexes, Signaling Growth and Potential FDA Approval
Tonix Pharmaceuticals' inclusion in the Russell 3000 and 2000 indexes highlights its market cap growth and the potential FDA approval of TNX-102 SL for fibromyalgia, marking a significant milestone for the company.
Nutriband Inc.'s AVERSA Technology Poised for FDA Approval with Significant Market Potential
Nutriband Inc.'s innovative AVERSA abuse-deterrent patch technology, targeting the misuse of transdermal patches like fentanyl, is on its way to FDA approval, with an estimated annual market potential of $800 million.
Tonix Pharmaceuticals Bolsters Leadership with Experienced Executive Joseph Hand
Tonix Pharmaceuticals strengthens its executive team by appointing Joseph Hand as General Counsel and EVP of Operations, bringing extensive corporate experience ahead of a potential FDA approval for its fibromyalgia treatment.
United Health Products Advances FDA Approval Process for Novel Hemostatic Agent
Medical device company United Health Products has made significant progress in its FDA approval process for CelluSTAT, a natural bleeding control agent, while securing funding and pursuing an uplisting to OTCQB. The development could lead to a new option in surgical bleeding control.