Amneal files again for FDA approval of first dihydroergotamine autoinjector
Amneal Pharmaceuticals has submitted another new drug application (NDA) for its dihydroergotamine (DHE) prefilled syringe autoinjector to treat tough-to-treat headaches,…
Central Nervous System
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Tris Pharma receives ex-US approvals for ADHD treatments
Tris Pharma has received additional ex-US approvals for its attention deficit hyperactivity disorder (ADHD) treatments, Quillivant XR and QuilliChew ER.…
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AC Immune’s stock jumps after Parkinson’s therapy shows signs of benefit
AC Immune’s stock price has jumped by more than 20% after all patients in a trial of its Parkinson’s disease…
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Zai Lab and argenx announce NMPA approval for sBLA for VYVGART Hytrulo
Zai Lab and argenx have announced receipt of approval from the National Medical Products Administration (NMPA) of China for the supplemental…
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Eisai lowers Leqembi revenue forecast after rocky entry to market
Eisai has lowered the sales forecast for its Alzheimer’s drug Leqembi (lecanemab), primarily citing delays in revenue in the US.…
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Intra-Cellular bolsters Caplyta data with another Phase III win
Having raised the full-year sales guidance for Caplyta (lumateperone) a week ago, Intra-Cellular Therapeutics has reported positive topline data from…
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NLS and Kadimastem stocks soar following merger agreement
Switzerland-based NLS Pharmaceutics and Israel-headquartered Kadimastem have signed a definitive merger agreement, with plans to form a joint biopharmaceutical aimed…
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Northwestern and Case Western Reserve universities develop Huntington’s therapy
Researchers from the US's Northwestern and Case Western Reserve universities have developed the first therapeutic that leverages polymers to treat…
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US court upholds Avadel’s narcolepsy drug approval amid exclusivity battle
The US District Court for the District of Columbia has upheld the decision by the US Food and Drug Administration…
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EC fines Teva $502m over multiple sclerosis treatment Copaxone practices
The European Commission (EC) has imposed a fine of €462.6m ($502m) on Teva Pharmaceuticals Industries after investigating the company’s practices…
