Definium Therapeutics Receives FDA Breakthrough Therapy Designation (BTD) for DT120 in MDD

Shots: Definium Therapeutics announced that the US FDA granted BTD to DT120 (lysergide) orally disintegrating tablet (ODT) for the treatment of major depressive disorder (MDD), following positive P-III results In the P-III Emerge study, a single 100 µg dose of DT120 ODT demonstrated an 8.1-point PBO-adjusted improvement in MADRS total score at wk. 6 (p<0.0001),…

ByPrince GiriSeptember 8, 2026

NEWS

Otsuka to Acquire Transcend Therapeutics for ~$1.225B

Shots: Otsuka, via its subsidiary Otsuka America, has entered into an agreement to fully acquire Transcend, with an aim to expand its portfolio in psychiatric & neurological indications As per the deal, Otsuka will acquire Transcend for $700M upfront, & ~$525M in sales milestones, representing the total deal value of ~$1.225B; closing is expected in…

ByRidhi RastogiMarch 30, 2026

INSIGHTS+

The US FDA New Drug Approvals in February 2026

Shots: Approval momentum strengthened in February 2026, with the US FDA clearing four new therapies across dermatology, psychiatry, and rare pediatric disorders highlighting both volume and therapeutic impact. Four notable therapies crossed the regulatory finish line, Acrotech Biopharma and Otsuka Pharmaceutical’s Adquey for mild-to-moderate atopic dermatitis, Vanda Pharmaceuticals’ Bysanti for acute bipolar I disorder and schizophrenia, Immedica Pharma’s Loargys for ARG1-D–related hyperargininemia, and Ascendis Pharma’s Yuviwel to improve growth in children with achondroplasia Overall, February 2026 reflected…

ByDipanshu DixitMarch 10, 2026

MAGAZINE

PharmaShots Magazine-September-2025 Edition

Medical psychedelics are a fascinating field that modern science has yet to comprehend completely. Researchers are still digging up, trying to find evidence-based outcomes to tap into a whole new opportunity in psychiatry and mental health medicines The September Edition unearths a brand-new perspective on psychedelics through engaging articles, illustrative infographics, trailing BioTrends, illuminating regulatory…

ByAditya SinghSeptember 11, 2025

THOUGHTSPOT

The Future of Personalized Medicine in Psychiatry and Substance Use Disorders

Mental health treatment has long followed a one-size-fits-all approach, with clinicians often relying on trial and error to find effective medications and therapies. However, the landscape is rapidly changing as personalized medicine emerges at the forefront of psychiatric care and addiction treatment. By integrating genetic insights, artificial intelligence, and digital health technologies, healthcare providers are…

ByAndrea LaceyMarch 20, 2025

Definium Therapeutics Receives FDA Breakthrough Therapy Designation (BTD) for DT120 in MDD

Otsuka to Acquire Transcend Therapeutics for ~$1.225B

The US FDA New Drug Approvals in February 2026

PharmaShots Magazine-September-2025 Edition

The Future of Personalized Medicine in Psychiatry and Substance Use Disorders

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