Endo International plc issued the following announcement on July 6.Endo International plc (NASDAQ: ENDP) today announced that it received U.S.
Advisory committee meeting scheduled for July 15, 2020
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.
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.
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).
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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. 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 issued the following announcement on July 2.Original source can be found here.
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 expects sales and shipments of the new test to begin in mid-July.
The new indication expansion significantly broadens the opportunities to address the geriatric fragility fracture market
First and only FDA-approved immunotherapy to demonstrate a significant overall survival benefit in the first-line setting in a Phase III study
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.
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, 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. 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.
FDA provides very specific guidelines to study iPSC-derived MSCs
The U.S. Food and Drug Administration approved Fintepla (fenfluramine), a Schedule IV controlled substance, for the treatment of seizures associated with Dravet syndrome in patients age 2 and older.
FUSION PPE Offers NIOSH and CDC Approved N95 Respirator Mask Produced by BYD, Backed by Warren Buffet, As Covid-19 Surges with Potential Second Wave, and FDA Reissues Emergency Use Authorizations (EUAs) Revising Which Respirators Can Be Decontaminated for Reuse
HemoShear Therapeutics, a clinical stage company developing treatments for rare metabolic disorders, has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to conduct a phase 2 clinical trial of HST5040, an oral small molecule drug for the treatment of patients with methylmalonic acidemia (MMA) and propionic acidemia (PA).