Wednesday, November 6, 2024

Wednesday, November 6, 2024

Regulation

INVERSAGO PHARMA: Receives Rare Pediatric Disease Designation from the FDA for INV-101 for the Treatment of Prader-Willi Syndrome

By Press release submission | Jan 8, 2021

Patients

GEMINI THERAPEUTICS: Announces FDA Fast Track Designation Granted for GEM103 for the Treatment of Dry Age-Related Macular Degeneration (AMD) in Patients With Complement Factor H (CFH) Loss of Function Gene Variants

By Press release submission | Jan 8, 2021

Regulation

FDA: Issues Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers and Clinical Laboratory Staff

By Press release submission | Jan 8, 2021

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MEDICURE: Announces Pivotal Phase 3 Trial IND Filing with FDA for Treatment of Seizures Associated with Pyridox(am)ine 5'-phosphate oxidase (PNPO) Deficiency

Regulation

By Press release submission | Jan 8, 2021

Medicure Inc. ("Medicure" or the "Company") (TSXV: MPH) (OTC: MCUJF), a cardiovascular pharmaceutical company, today announced that through its Barbados subsidiary, Medicure International Inc., it intends to file an Investigational New Drug ("IND") application with the U.S. Food and Drug Administration ("FDA") pertaining to its legacy product Pyridoxal 5′-phosphate ("P5P", also referred to as "MC-1") for the treatment of seizures associated with pyridox(am)ine 5'-phosphate oxidase ("PNPO") deficiency.

UNION THERAPEUTICS A/S: Receives FDA Approval for Ind of Oral Next Generation Pde4-inhibitor (Orismilast) for Investigation in Plaque Psoriasis

FDA Approval

By Press release submission | Jan 8, 2021

Orismilast is a next generation oral PDE4-inhibitor with an improved therapeutic window compared to other PDE4-inhibitors

REDHILL BIOPHARMA: RHB-204 Granted FDA Fast Track Designation for NTM Disease

Regulation

By Press release submission | Jan 8, 2021

U.S. Phase 3 study underway to evaluate RHB-204 as a first-line, stand-alone, oral treatment for pulmonary NTM disease - a rare condition with no FDA-approved first-line therapy

BIONIZ: Announces Positive End of Phase 2 Meeting with the FDA for BNZ-1 for the Treatment of Refractory Cutaneous T-Cell Lymphoma

Patients

By Press release submission | Jan 8, 2021

Bioniz Therapeutics, Inc., ("Bioniz"), a clinical-stage biopharmaceutical company advancing a pipeline of first-in-class peptide-based multi-cytokine inhibitors for the treatment of cancer and autoimmune diseases, announced today that the U.S. Food and Drug Administration (FDA) provided positive feedback during the company's end of Phase 2 (EOP2) meeting for Bioniz's BNZ-1.

AMBRX INC.: FDA Grants ARX788 Fast Track Designation for HER2-positive Metastatic Breast Cancer

Patients

By Press release submission | Jan 6, 2021

Ambrx announced that the U.S. Food and Drug Administration (FDA) granted ARX788 Fast Track Designation as monotherapy for the treatment of advanced or metastatic HER2-positive breast cancer patients who have received one or more prior anti-HER2 based regimens in the metastatic setting.

FDA: Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines

Regulation

By Press release submission | Jan 6, 2021

Two different mRNA vaccines have now shown remarkable effectiveness of about 95% in preventing COVID-19 disease in adults. As the first round of vaccine recipients become eligible to receive their second dose, we want to remind the public about the importance of receiving COVID-19 vaccines according to how they’ve been authorized by the FDA in order to safely receive the level of protection observed in the large randomized trials supporting their effectiveness.

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  1. 1 TRICVALVE®: Transcatheter Bicaval Valves System granted Designation as Breakthrough Device by the U.S. Food and Drug Administration (FDA)
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