Stemline Therapeutics’ breast cancer treatment approved
The Menarini Group, an Italian pharmaceutical and diagnostics company, says that the U.S. Food and…
January 31, 2023 - 3 minutes
Regulatory approval
Stargardt disease treatment gets FDA fast track
Nanoscope Therapeutics Inc., a clinical-stage biotechnology company developing gene therapies for retinal degenerative diseases, has…
January 31, 2023 - 2 minutes
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…
January 31, 2023 - 4 minutes
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…
January 27, 2023 - 2 minutes
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…
January 27, 2023 - 4 minutes
Milestone for gene-edited therapy for sickle cell disease
Vertex Pharmaceuticals (Europe) and CRISPR Therapeutics have announced that the European Medicines Agency (EMA) has…
January 26, 2023 - 3 minutes
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…
January 11, 2023 - 3 minutes
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…
January 4, 2023 - 2 minutes
Legend Biotech new drug application approved in China
Legend Biotech Corporation has announced that China’s National Medical Products Administration (NMPA) has formally accepted…
January 3, 2023 - 3 minutes
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…
December 20, 2022 - 6 minutes
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…
December 20, 2022 - 3 minutes
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.…
December 19, 2022 - 2 minutes
