FDA Approvals
HeartBeam to Discuss Q3 2025 Results and Regulatory Progress in November Conference Call
HeartBeam will host a conference call on November 13, 2025, to discuss third-quarter results and provide updates on its FDA-cleared 3D ECG technology that could transform remote cardiac monitoring.
FDA Approves One-Minute HIV Self-Test in Major Public Health Advancement
The FDA's approval of bioLytical's INSTI® HIV Self Test, which provides results in 60 seconds, represents a significant step toward reducing undiagnosed HIV cases and supporting national goals to end the HIV epidemic by making testing more accessible and private.
HeartBeam Receives FDA Clearance for Revolutionary Cable-Free ECG System
HeartBeam Inc. has obtained FDA clearance for its groundbreaking cable-free 12-lead ECG system that enables remote cardiac monitoring, potentially transforming how patients and physicians access critical arrhythmia data outside traditional clinical settings.
NRx Pharmaceuticals' Depression Treatment Receives FDA Fast Track Designation
NRx Pharmaceuticals' NRX-100 received FDA Fast Track designation for treating suicidal ideation, potentially expanding its market to 13 million U.S. adults and offering a novel approach targeting neuroplasticity in depression treatment.
Calidi Biotherapeutics Inc. Receives FDA Fast Track Designation for CLD-201 in Soft Tissue Sarcoma
Calidi Biotherapeutics Inc. has been granted FDA Fast Track designation for its CLD-201 treatment, marking a significant step forward in the development of therapies for soft tissue sarcoma and other cancers.
Nutriband Inc. Announces Key Dates for 25% Preferred Stock Dividend
Nutriband Inc. (NASDAQ: NTRB) has set important dates for its 25% preferred stock dividend, linking the dividend's value to the FDA approval of its AVERSA Fentanyl product, marking a significant milestone for shareholders and the company's growth in the pharmaceutical sector.
Nutriband Inc. Announces 25% Preferred Stock Dividend Tied to AVERSA Fentanyl FDA Approval
Nutriband Inc. (NASDAQ: NTRB) has declared a 25% preferred stock dividend, contingent on FDA approval of its AVERSA Fentanyl product, highlighting its strategy to enhance shareholder value during the product's commercialization phase.