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FDA approves Doptelet for thrombocytopenia in chronic liver disease
The FDA has approved Doptelet tablets to treat low blood platelet count in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure...
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U.S. Food and Drug Administration (FDA)
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FDA expands approval of Gilenya to treat multiple sclerosis in paediatric patients
The FDA has approved Gilenya to treat relapsing multiple sclerosis in children and adolescents age 10 years and older...
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Osteoporosis drug may benefit heart health
The osteoporosis drug alendronate was linked with a reduced risk of cardiovascular death, heart attack and stroke...
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FDA approves Briviact for partial-onset seizures in paediatric epilepsy
The approval provides paediatric epilepsy patients a treatment option which can be initiated at a therapeutic dose from day one...
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FDA approves Tafinlar-Mekinist combination for the treatment of ATC
The U.S. Food and Drug Administration has approved Tafinlar and Mekinist administered together, for the treatment of anaplastic thyroid cancer that cannot be removed by surgery...
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Federal judge enters consent decree against outsourcing facility
U.S. District Judge Robert J. Shelby entered a consent decree of permanent injunction between the United States and Isomeric Pharmacy Solutions...
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FDA advances the development of innovative products for OUD
The FDA has announced its latest action to encourage and support the development of treatment options for people with opioid use disorder...
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FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia
The FDA has approved Crysvita, the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia, a rare, inherited form of rickets...
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KL1333 receives FDA ODD for mitochondrial diseases
NeuroVive Pharmaceutical AB has been granted Orphan Drug Designation for its project KL1333 for treatment of inherited mitochondrial respiratory chain diseases...
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First-in-Human trial of cannabis-based therapy for Parkinson’s initiated
GB Sciences, Inc. is planning to file an Exploratory IND and perform a Phase 0 Clinical Trial to gather valuable First-In-Human data on its proprietary cannabis-based therapies...
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FDA expands approval of Adcetris for Stage III or IV classical Hodgkin lymphoma
The FDA has approved Adcetris to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma in combination with chemotherapy...
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FDA approves tests to screen for tickborne parasite in whole blood and plasma
The FDA has approved tests intended to be used as donor screening tests on samples from individual human donors, including volunteer donors of whole blood and blood components...
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Trogarzo approved for HIV patients with limited treatment options
The FDA has approved Trogarzo for adult patients whose HIV infections cannot be successfully treated...
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FDA expands approval of Imfinzi to reduce the risk of NSCLC progression
The FDA has approved Imfinzi for the treatment of patients with stage III non-small cell lung cancer whose tumours are not able to be surgically removed and whose cancer has not progressed after treatment...
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Psoriasis drug found to reduce aortic vascular inflammation
An antibody used to treat the skin disease psoriasis is also effective at reducing aortic inflammation, a key marker of future risk of major cardiovascular events...
