First and only FDA-approved immunotherapy to demonstrate a significant overall survival benefit in the first-line setting in a Phase III study
The new indication expansion significantly broadens the opportunities to address the geriatric fragility fracture market
Qualigen expects sales and shipments of the new test to begin in mid-July.
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.
Camargo Pharmaceutical Services issued the following announcement on July 2.Original source can be found here.
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.
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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.
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).
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.
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.
Advisory committee meeting scheduled for July 15, 2020
Endo International plc issued the following announcement on July 6.Endo International plc (NASDAQ: ENDP) today announced that it received U.S.
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).
Updated Label Now Includes Pediatric Patients with Lower Limb Spasticity Caused by Cerebral Palsy
MedAlliance has announced enrollment of the first patient in its study of SELUTION SLR™ 014 DEB for the treatment of In-Stent Restenosis (ISR).
Portfolio Expansion Ensures Dogs and Puppies 8 Weeks of Age and Older Receive Early, Broad-Spectrum Protection Against Fleas and Ticks
BRILINTA in combination with aspirin could be the first FDA-approved dual antiplatelet therapy to reduce the rate of stroke in these high-risk patients
Designed to enhance bone growth and help achieve fusion in surgeries involving the skeletal system
If approved, terlipressin would be the first FDA-approved treatment in the United States for adult patients with HRS-1, a life-threatening condition
Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, announced that the US Food and Drug Administration (FDA) has granted APG-2575, a novel Bcl-2 inhibitor being developed by the company, an Orphan Drug Designation (ODD) for the treatment of Waldenström macroglobulinemia (WM).