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Home » What’s new » Regulatory approval

Regulatory approval

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News and Trends

Stemline Therapeutics’ breast cancer treatment approved

The Menarini Group, an Italian pharmaceutical and diagnostics company, says that the U.S. Food and…

By Jim Cornall
January 31, 2023 - 3 minutes
News and Trends

Stargardt disease treatment gets FDA fast track

Nanoscope Therapeutics Inc., a clinical-stage biotechnology company developing gene therapies for retinal degenerative diseases, has…

By Jim Cornall
January 31, 2023 - 2 minutes
News and Trends

Abbisko Therapeutics receives breakthrough therapy designation for CSF-1R inhibitor 

Abbisko Therapeutics Co., Ltd. has announced that its CSF-1R inhibitor Pimicotinib has been granted the…

By Jim Cornall
January 31, 2023 - 4 minutes
News and Trends

EMA accepts Marketing Authorization Application for lecanemab to treat early Alzheimer’s disease

BioArctic AB's partner Eisai says the European Medicines Agency (EMA) has accepted a marketing authorization…

By Jim Cornall
January 27, 2023 - 2 minutes
News and Trends

Dupixent gets EU nod for children with severe atopic dermatitis

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive…

By Jim Cornall
January 27, 2023 - 4 minutes
News and Trends

Milestone for gene-edited therapy for sickle cell disease

Vertex Pharmaceuticals (Europe) and CRISPR Therapeutics have announced that the European Medicines Agency (EMA) has…

By Jim Cornall
January 26, 2023 - 3 minutes
News and Trends

AstraZeneca’s Airsupra gets US approval as new rescue treatment for asthma

Avillion LLP says the US Food and Drug Administration (FDA) has approved AstraZeneca’s Airsupra for…

By Jim Cornall
January 11, 2023 - 3 minutes
News and Trends

Infex’s novel AMR drug candidate MET-X receives FDA QIDP designation

Infex Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has granted qualified…

By Jim Cornall
January 4, 2023 - 2 minutes
News and Trends

Legend Biotech new drug application approved in China

Legend Biotech Corporation has announced that China’s National Medical Products Administration (NMPA) has formally accepted…

By Jim Cornall
January 3, 2023 - 3 minutes
In Depth

Ebvallo approval ushers in off-the-shelf T-cell immunotherapies

Patient-derived CAR-T immunotherapies have dominated the cancer immunotherapy space over the last decade. The EU…

By Jonathan Smith
December 20, 2022 - 6 minutes
News and Trends

F2G looks for FDA new drug application approval for invasive fungal infections treatment 

F2G Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted for…

By Jim Cornall
December 20, 2022 - 3 minutes
News and Trends

Jacobio’s cancer treatment given breakthrough therapy designations by China CDE

Jacobio Pharma’s in-house KRAS G12C inhibitor JAB-21822 has been granted breakthrough therapy designations in China.…

By Jim Cornall
December 19, 2022 - 2 minutes
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