IMMUNICUM AB (PUBL): Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC)
Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC)
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AMPIO: Receives feedback from the FDA on Ampio's Proposed Modifications to the special protocol assessment for Ampion treatment of severe Osteoarthritis of the knee
Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, announced today it has received guidance from the U.S Food & Drug Administration ("FDA") regarding the impact of COVID-19 on its Phase III clinical trial for osteoarthritis of the knee ("OAK").
PFIZER: LORBRENA® (lorlatinib) sNDA in Previously Untreated ALK-Positive Lung Cancer Accepted for Priority Review by U.S. FDA
Supplemental New Drug Application being reviewed under FDA Real-Time Oncology Review (RTOR) and Project ORBIS pilot programs
CYTODYN INC.: FDA Accepts Protocol for Adding an Open-Label Extension to CytoDyn’s Phase 3 Trial for Severe-to-Critical COVID-19 Patients
The agency also provided specific guidance for inclusion/exclusion criteria for patients seeking leronlimab under eIND authorization
FDA: Takes Steps to Provide Clarity on Developing New Drug Products in the Age of Individualized Medicine
Advances in scientific knowledge and drug development technology have provided an opportunity for new approaches to drug development, including the development of drugs for the treatment of rare diseases.
FDA: Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines
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.
AMBRX INC.: FDA Grants ARX788 Fast Track Designation for HER2-positive Metastatic Breast Cancer
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.
BIONIZ: Announces Positive End of Phase 2 Meeting with the FDA for BNZ-1 for the Treatment of Refractory Cutaneous T-Cell Lymphoma
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.
REDHILL BIOPHARMA: RHB-204 Granted FDA Fast Track Designation for NTM Disease
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
UNION THERAPEUTICS A/S: Receives FDA Approval for Ind of Oral Next Generation Pde4-inhibitor (Orismilast) for Investigation in Plaque Psoriasis
Orismilast is a next generation oral PDE4-inhibitor with an improved therapeutic window compared to other PDE4-inhibitors
MEDICURE: Announces Pivotal Phase 3 Trial IND Filing with FDA for Treatment of Seizures Associated with Pyridox(am)ine 5'-phosphate oxidase (PNPO) Deficiency
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.
FDA: Issues Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers and Clinical Laboratory Staff
Impact on molecular tests remains low
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
Gemini Therapeutics, a clinical stage precision medicine company developing innovative treatments for genetically defined age-related macular degeneration (AMD), announced that GEM103, the Company’s investigational treatment for dry AMD, has been granted Fast Track designation by the United States Food and Drug Administration (FDA).
INVERSAGO PHARMA: Receives Rare Pediatric Disease Designation from the FDA for INV-101 for the Treatment of Prader-Willi Syndrome
Inversago Pharma Inc. (“the Company” or “Inversago”), the peripheral CB1 blockade company, today announced the U.S. Food and Drug Administration (FDA) granted a Rare Pediatric Disease (RPD) designation to the Company’s lead compound, INV-101, for the treatment of Prader-Willi syndrome (PWS).