FDA assigns priority-review designation for ELIQUIS NDA for stroke prevention in atrial fibrillation
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Comments (0)EMA recommends 4SC’s resminostat for orphan medicinal product designation to treat HL
4SC AG, a discovery and development company of targeted small molecule drugs for autoimmune diseases and cancer, today announced that the European Medicines Agency (EMA) has recommended 4SC's anti-cancer compound resminostat for designation as orphan medicinal product for the treatment of Hodgkin's Lymphoma (HL), a cancer of the lymphatic system.
Liver Cancer Drug Provectus Receives Orphan Drug Designation From FDA
The U.S. Food and Drug Administration (FDA) has given orphan drug designation to Provectus Pharmaceuticals, Inc., for Rose Bengal, the active component in their new oncology medication PV-10. The drug is designed for the treatment of hepatocellular carcinoma (HCC), the most prevalent form of liver cancer. At present Provectus is ...
FDA grants orphan drug designation for Avedro’s VibeX to treat Keratoconus
Avedro, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the Company's VibeX for use with its KXL System (UVA irradiation) for Corneal Cross-linking to treat Keratoconus.
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FDA Grants Fast Track Designation For Alpharadin For Castration Resistant Prostate Cancer In Patients With Bone Metastases
Investigational drug Alpharadin (radium-223 chloride) for the treatment of castration-resistant prostate cancer in patients whose cancer has spread to the bone (bone metastasis) has been granted Fast Track designation by the FDA (Food and Drug Administration), Bayer Health Care announced today. Alpharadin is exclusively licenced to Bayer from Algeta ASA. ...
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KRN5500 For Chemotherapy-Induced Neuropathic Pain In Cancer Patients Gets Fast Track Designation By FDA, USA
According to today's announcement by DARA BioSciences, Inc., the U.S. Food and Drug Administration (FDA) granted a fast track designation to for their investigational drug KRN5500 for the treatment of chemotherapy-induced neuropathic pain in cancer patients. DARA's KRN5500 achieved positive results in its Phase II clinical trial (DTCL100), ...
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DARA Receives US FDA Fast Track Designation For KRN5500
DARA BioSciences, Inc. (NASDAQ: DARA) announced that its investigational drug KRN5500 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of chemotherapy-induced neuropathic pain in patients with cancer. The FDA's Fast Track program is designed to facilitate the development and expedite the ...
FDA grants Orphan Drug Designation to Kamada’s AAT product for treating type 1 diabetes
Kamada LTD., a bio-pharmaceutical company engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, was granted an Orphan Drug Designation for its Alpha-1 Antitrypsin (AAT) product to treat type 1 diabetes.
Medivir: TMC435 Has Received Fast Track Designation From The FDA And TMC435 Will Be Studied In Combination With Pharmasset’s PSI-7977 For HCV
Medivir AB (OMX: MVIR), is an emerging research-based specialty pharmaceutical company focused on infectious diseases. Medivir today announced that its investigational protease inhibitor TMC435 has received "Fast Track" designation by the U.S. Food and Drug Administration ("FDA") for the treatment of chronic hepatitis C (CHC) genotype-1 infection. This is based ...
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TMC435 Has Received Fast Track Designation From The FDA And TMC435 Will Be Studied In Combination With Pharmasset’s PSI-7977 For HCV Genotype-1
Medivir today announced that its investigational protease inhibitor TMC435 has received "Fast Track" designation by the U.S. Food and Drug Administration ("FDA") for the treatment of chronic hepatitis C (CHC) genotype-1 infection. This is based on TMC435's potential to address unmet medical needs in the treatment of CHC infection compared ...
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Repligen Receives U.S. Fast Track Designation And European Orphan Medicinal Product Recommendation For RG3039 For Spinal Muscular Atrophy
Repligen Corporation (NASDAQ: RGEN) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for RG3039, a potential treatment for Spinal Muscular Atrophy (SMA). Fast Track is a process designed to facilitate the development and expedite the review of drugs that treat serious diseases and ...
Stanford Awarded Designation Of Level-2 Pediatric Trauma Center
Stanford's trauma center has been verified as a level-2 pediatric trauma center by the American College of Surgeons. The new status takes into account trauma treatment capabilities of the pediatric emergency department as well as the ability of Lucile Packard Children's Hospital to offer such services as pediatric surgery, ...