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NEWS

Vanda Pharmaceuticals
Vanda Pharmaceuticals Reports the US FDA’s Approval of Bysanti (Milsaperidone) for Acute Bipolar I Disorder & Schizophrenia
Shots: FDA has approved Bysanti, an active metabolite of iloperidone, as a 1L therapy for acute treatment of adults with manic or mixed episodes associated with bipolar I disorder & for schizophrenia, with the latest patent expiring in 2044 & commercial availability expected in Q3’26 In clinical trials, Bysanti showed bioequivalence to Fanapt (iloperidone) across the full…
February 23, 2026
Roche
The US FDA Accepts Roche’s Giredestrant NDA for ESR1-Mutated, ER-Positive Advanced Breast Cancer
Shots: The US FDA has accepted Roche’s NDA for giredestrant in combination with everolimus to treat adults with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer following recurrence or progression on prior endocrine-based therapy NDA acceptance is based on P-III (evERA) study data showing giredestrant + everolimus reduced the risk of disease progression or…
February 20, 2026
Candel Therapeutics and RTW Enter Royalty Funding Agreement to Support the Launch Aglatimagene Besadenovec in Localized Prostate Cancer
Shots: Candel Therapeutics has entered into a $100M royalty funding agreement with RTW Investments, contingent on FDA approval of Aglatimagene Besadenovec (CAN-2409) for intermediate- to high-risk localized prostate cancer As per the deal, RTW will receive a capped, tiered single-digit percentage of US annual net sales of aglatimagene. Candel Plans to submit a BLA for…
February 20, 2026
NexEos Bio Receives US FDA IND Clearance to Advance NTX-1024 into P-II/III Study for Vernal Keratoconjunctivitis
Shots: The US FDA has cleared NexEos Bio’s IND application to initiate a P-II/III clinical study of NTX-1024 ophthalmic solution for the treatment of vernal keratoconjunctivitis (VKC) The P-II/III study will evaluate the safety and efficacy of NTX-1024 in VKC, following positive results from an open-label investigator-initiated study showing improvements in symptoms and ocular inflammation…
February 20, 2026
Novartis
Novartis AG to Transfer Stake in Novartis India Limited to ChrysCapital
Shots: Novartis AG has signed an agreement with ChrysCapital to divest its 70.68% stake in Novartis India Limited (NIL), following a strategic review initiated in Feb 2024 The transaction, subject to customary closing conditions, is expected to close in Q3’26; the Board of NIL was formally notified post-signing Post-divestment, Novartis will further its transition into…
February 20, 2026
Hims & Hers to Acquire Eucalyptus for ~$1.15B
Shots: Hims & Hers has entered into a definitive agreement to acquire Eucalyptus, to expand into Australia and Japan, and deepen its presence in the UK, Germany, and Canada As per the deal, Hims & Hers will acquire Eucalyptus for up to ~$1.15B, including upfront ~$240M in cash The acquisition is expected to close mid-2026,…
February 20, 2026
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