Vicore’s lung disease digital therapy gets breakthrough tag
pharmaphorum
MARCH 20, 2024
Vicore gets FDA breakthrough status for Almee, a cognitive behavioural therapy (CBT) digital health therapy used to support people with pulmonary fibrosis
pharmaphorum
MARCH 20, 2024
Vicore gets FDA breakthrough status for Almee, a cognitive behavioural therapy (CBT) digital health therapy used to support people with pulmonary fibrosis
pharmaphorum
APRIL 11, 2024
Roche and Eli Lilly have been granted breakthrough status by the FDA for their pTau217 blood test for Alzheimer's disease.
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pharmaphorum
MARCH 14, 2024
Cybin files a $150m placement on the back of new clinical data with its psychedelic drug CYB003 for depression and an FDA breakthrough designation.
pharmaphorum
JANUARY 4, 2024
Digital health company Click Therapeutics has won an FDA breakthrough device designation for CT-155, a digital therapeutic (DTx) for the negative symptoms of schizophrenia, like social withdrawal and apathy, that tend not to respond well to antipsychotic drugs.
pharmaphorum
MARCH 8, 2024
In another inflection point for the psychedelic medicines category, Mind Medicine (MindMed) has claimed breakthrough status from the FDA for its LSD-based treatment candidate MM120 as a treatment for anxiety.
Pharmaceutical Technology
SEPTEMBER 30, 2022
Spark Therapeutics’ Luxturna, indicated for inherited retinal disease (IRD), was the first gene therapy to be approved, in 2017, with a price tag of $850,000 for each eye. Prior to bluebird's approvals, there were only two FDA-approved gene therapies for inherited conditions on the market.
Pharmaceutical Technology
MAY 19, 2023
DMTs for MS have a high price tag, particularly in the US. The development and approval of safe and reliable curative therapies would be a major breakthrough in the treatment of MS, with considerable implications for patients’ financial circumstances and health-related quality of life.
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