MEDALLIANCE: World's First FDA IDE Coronary Patient Treated With a DEB
MedAlliance has announced enrollment of the first patient in its study of SELUTION SLR™ 014 DEB for the treatment of In-Stent Restenosis (ISR).
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ABBVIE: FDA Approves Expanded BOTOX® (onabotulinumtoxinA) Label for the Treatment of Pediatric Patients with Spasticity
Updated Label Now Includes Pediatric Patients with Lower Limb Spasticity Caused by Cerebral Palsy
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FDA: Approves New Therapy for Myelodysplastic Syndromes (MDS) That Can Be Taken at Home
The U.S. Food and Drug Administration approved Inqovi (decitabine and cedazuridine) tablets for treatment of adult patients with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML).
ENDO INTERNATIONAL: U.S. FDA Approves Qwo™ (collagenase clostridium histolyticum-aaes), the First Injectable Treatment for Cellulite
Endo International plc issued the following announcement on July 6.Endo International plc (NASDAQ: ENDP) today announced that it received U.S.
MALLINCKRODT: Confirms that U.S. Food and Drug Administration (FDA) Will Convene an Advisory Committee to Review Terlipressin for the Treatment of Patients with Hepatorenal Syndrome Type 1 (HRS-1)
Advisory committee meeting scheduled for July 15, 2020
SENHWA BIOSCIENCES: Silmitasertib Receives Rare Pediatric Disease Designation from U.S. FDA for Treatment of Recurrent Sonic Hedgehog Medulloblastoma
Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company focused on Next Generation DNA Damage Response (DDR) therapeutics for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease (RPD) Designation for its drug Silmitasertib, a Casein Kinase 2 (CK2) inhibitor, being developed as a treatment for recurrent sonic hedgehog (SHH) medulloblastoma.
FDA: Coronavirus (COVID-19) Update: FDA Issued Emergency Use Authorization for Point of Care Antigen Test
The U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) for a COVID-19 antigen diagnostic test, the BD (Becton Dickinson) Veritor System for Rapid Detection of SARS-CoV-2.
FDA: Coronavirus (COVID-19) Update: FDA Authorizes Additional COVID-19 Combination Diagnostic Test Ahead of Flu Season
U.S. Food and Drug Administration further assisted health care providers around the country prepare for the upcoming flu season during the COVID-19 pandemic by issuing an emergency use authorization (EUA) for the third diagnostic test for detection and differentiation of the viruses that cause flu and COVID-19 in individuals suspected of COVID-19 by their healthcare provider to the U.S. Centers for Disease Control and Prevention (CDC).
FDA: Approves New HIV Treatment for Patients With Limited Treatment Options
The U.S. Food and Drug Administration approved Rukobia (fostemsavir), a new type of antiretroviral medication for adults living with HIV who have tried multiple HIV medications and whose HIV infection cannot be successfully treated with other therapies because of resistance, intolerance or safety considerations.
METVITAL, INC.: Announces FDA Fast Track Designation of Anhydrous Enol-Oxaloacetate (AEO) for the Treatment of Patients with Newly Diagnosed Glioblastoma Multiforme
MetVital, Inc. issued the following announcement on July 1.MetVital, Inc., a privately held biopharmaceutical company developing small molecule modulators of altered glutamate metabolism for the treatment of diseases with significant unmet medical need and commercial potential, today announces that the U.S.
CAMARGO PHARMACEUTICAL SERVICES: Camargo client Chiasma receives FDA approval for first and only oral somatostatin analog for long-term maintenance treatment of acromegaly
Camargo Pharmaceutical Services issued the following announcement on July 2.Original source can be found here.
BLUEPRINT MEDICINES: Announces Submission of New Drug Application to FDA for Pralsetinib for the Treatment of Advanced RET Mutant and RET Fusion-Positive Thyroid Cancers
Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for pralsetinib for the treatment of patients with advanced or metastatic RET mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancers.
QUALIGEN THERAPEUTICS: Submits Notification to FDA to Commence Distribution of its FastPack® COVID-19 Antibody Test
Qualigen expects sales and shipments of the new test to begin in mid-July.
ILLUMINOSS MEDICAL: Receives FDA Clearance for Expanded Clinical Use for Pelvic, Clavicle and Small-Bone Fractures
The new indication expansion significantly broadens the opportunities to address the geriatric fragility fracture market
EMD SERONO: FDA Approves BAVENCIO as First-Line Maintenance Treatment for Patients with Locally Advanced or Metastatic Urothelial Carcinoma
First and only FDA-approved immunotherapy to demonstrate a significant overall survival benefit in the first-line setting in a Phase III study
FDA: Approves First-Line Immunotherapy for Patients with MSI-H/dMMR Metastatic Colorectal Cancer
U.S. Food and Drug Administration approved Keytruda (pembrolizumab) for intravenous injection for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
FDA: Approves Breast Cancer Treatment That Can Be Administered At Home By Health Care Professional
U.S. Food and Drug Administration approved Phesgo—a combination of pertuzumab, trastuzumab and hyaluronidase–zzxf—for injection under the skin to treat adult patients with HER2-positive breast cancer that has spread to other parts of the body, and for treatment of adult patients with early HER2-positive breast cancer. Patients should be selected based on an FDA-approved companion diagnostic test.
CELLTEX THERAPEUTICS: Receives Another FDA Approval: Phase II Clinical Trial Using Mesenchymal Stem Cells (MSCs) as a Prophylactic Against COVID-19
Celltex, a Houston, Texas-based biotechnology company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to proceed with the Company’s Investigational New Drug application (IND 22055) to investigate the Prophylactic Efficacy of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) Against Coronavirus Disease 2019 (COVID-19).
NEXUS PHARMACEUTICALS, INC.: Announces Launch of Emerphed™ (ephedrine sulfate) RTU Injection, the First and Only FDA-approved, Ready-to-Use Ephedrine Injection (50 mg/10 mL vial)
Nexus Pharmaceuticals, Inc. issued the following announcement on June 26.Nexus Pharmaceuticals announced that it has launched its patent-pending New Drug Application (NDA) Emerphed, the first and only premixed ephedrine in a ready-to-use 50 mg/10 mL vial.
CITIUS: Receives FDA Response on Pre-Investigational New Drug (PIND) Application for its Induced Mesenchymal Stem Cells (iMSCs) to Treat Acute Respiratory Distress Syndrome (ARDS) in Patients with COVID-19
FDA provides very specific guidelines to study iPSC-derived MSCs