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neurocare Receives the US FDA’s Clearance for Apollo TMS Therapy Devices to Treat Major Depressive Disorder in Adolescents

Shots:neurocare has received US FDA clearance for its Apollo Transcranial Magnetic Stimulation (TMS) Therapy devices to treat major depressive disorder (MDD) in adolescentsThe Apollo TMS Therapy system is a non-invasive treatment that uses a magnetic coil on the head to stimulate targeted brain pathways, with about 60% of patients achieving remission with TMS…
September 11, 2025

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NEWS

AbbVie Acquires Gilgamesh Pharmaceuticals’ Bretisilocin to Expand Psychiatry Pipeline for ~$1.2B

Shots:AbbVie has signed a definitive agreement to acquire Gilgamesh Pharmaceuticals’ Bretisilocin for moderate-to-severe major depressive disorder (MDD), currently in clinical developmentAs per the deal, AbbVie will acquire Gilgamesh’s bretisilocin program for ~$1.2B, including upfront and milestone payments. Gilgamesh will spin off Gilgamesh Pharma Inc. to retain its team and other programs, including blixeprodil…
August 26, 2025

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neurocare Receives the US FDA’s Clearance for Apollo TMS Therapy Devices to Treat Obsessive Compulsive Disorder

Shots:neurocare has received US FDA clearance for its Apollo Transcranial Magnetic Stimulation (TMS) Therapy devices to treat obsessive-compulsive disorder (OCD)The Apollo TMS Therapy system is a non-invasive treatment that uses a magnetic coil on the head to stimulate targeted brain pathways and was previously cleared for major depressive disorderThe systems support advanced…
August 21, 2025

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Aytu and Fabre-Kramer
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Aytu BioPharma Collaborates with Fabre-Kramer Pharmaceuticals to Commercialize Exxua (Gepirone) in the US for Major Depressive Disorder

Shots:Aytu has collaborated with Fabre-Kramer to commercialize Exxua in the US for treating major depressive disorder; launch is expected in Q4’25As per the deal, Fabre-Kramer has received $3M upfront & is eligible to receive $3M within 45 days of the Exxua’s 1yr. commercial sale, increasing to $5M if net sales reach $35M as…
June 9, 2025

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Vanda Pharmaceuticals
NEWS

Vanda Pharmaceuticals Reports the US FDA’s NDA Acceptance of Bysanti (Milsaperidone) for Acute Bipolar I Disorder & Schizophrenia

Shots:The US FDA has accepted NDA of Bysanti, an active metabolite of iloperidone to treat acute bipolar I disorder & schizophrenia (PDUFA: Feb 21, 2026). If approved, Bysanti may receive 5yrs. of data exclusivity, with pending patents extending into the 2040sNDA is backed by various iloperidone trials, incl. 2 in acute schizophrenia, 1…
May 6, 2025

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