Stokes’ STK-001 secures FDA orphan drug designation for Dravet Syndrome
Stokes’ STK-001 secures FDA orphan drug designation for Dravet Syndrome
US biotech company Stoke Therapeutics has secured orphan drug designation for its lead product candidate – STK-001 from the US Food and Drug Administration (FDA) for the treatment for Dravet syndrome. Considered to be a severe and progressive genetic epilepsy, Dravet syndrome is characterized by frequent, prolonged and refractory seizures that start within the first […]
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Astellas doses first patient in phase 3 VMS trial of fezolinetant
Japanese pharma company Astellas Pharma has dosed the first patient in the SKYLIGHT 1 phase 3 trial for fezolinetant, an investigational oral, non-hormonal compound for the treatment of moderate-to-severe vasomotor symptoms (VMS) associated with menopause. Vasomotor symptoms are hot flashes and night sweats which occur in nearly 57% on women, aged 40-64 years as per […]
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Foamix files NDA seeking FMX103 FDA approval for rosacea
Israeli pharma company Foamix Pharmaceuticals has filed a new drug application (NDA) for FMX103 to the US Food and Drug Administration (FDA) seeking FMX103 FDA approval for moderate-to-severe papulopustular rosacea in patients, aged 18 years and over. Considered to be a common skin condition, rosacea results in redness and visible blood vessels in the face. […]
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TRACON begins phase 1 TJD5 clinical trial in advanced solid tumors
TJD5 clinical trial : US biopharma company TRACON Pharmaceuticals has dosed the first patient in a US phase 1 clinical trial of I-Mab Biopharma’s CD73 antibody TJD5 (TJ004309) in patients with advanced solid tumors. TJD5 will be dosed in the early-stage trial as a single agent and also in combination with Roche’s PD-L1 antibody TECENTRIQ […]
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Cyxone achieves safety, tolerability goals in T20K MS clinical trial
T20K MS clinical trial : Swedish biotech company Cyxone said that a phase 1 clinical trial for its drug candidate T20K for multiple sclerosis (MS) has confirmed its safety and tolerability in humans. Cyxone said that there were no serious adverse events in the early-stage infusion study. As the next step in its development program, […]
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Daiichi Sankyo bags Turalio FDA approval for tenosynovial giant cell tumor
Turalio FDA approval : Daiichi Sankyo has secured approval for its CSF1R inhibitor Turalio (pexidartinib) from the US Food and Drug Administration (FDA) for the treatment of tenosynovial giant cell tumor (TGCT). The FDA approval of Turalio is for the treatment of adult patients having symptomatic tenosynovial giant cell tumor associated with severe morbidity or […]
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Bayer, Orion secures Darolutamide FDA approval for prostate cancer
Darolutamide FDA approval : German pharma giant Bayer and Finnish pharma company Orion have secured approval from the US Food and Drug Administration (FDA) for their non-steroidal androgen receptor inhibitor (ARi) Nubeqa (darolutamide) for the treatment of men having non-metastatic castration-resistant prostate cancer (nmCRPC). The FDA approval of darolutamide was driven on the findings of […]
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RESET clinical trial results : Rivipansel flops in phase 3 trial in SCD
RESET clinical trial results : US pharma giant Pfizer’s rivipansel failed to meet the primary and key secondary efficacy endpoints of a phase 3 trial called RESET in sickle cell disease (SCD). The aim of the RESET clinical trial was to assess the efficacy and safety of rivipansel in sickle cell disease patients, aged six […]
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Verdiperstat phase 3 MSA clinical trial : Biohaven enrolls first patient
Verdiperstat phase 3 MSA clinical trial : US biopharma company Biohaven Pharmaceutical has enrolled the first patient in a phase
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