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NEWS

Deciphera Pharmaceuticals Reports the EC’s Approval of Romvimza for Symptomatic Tenosynovial Giant Cell Tumor (TGCT)

Shots: The EC has approved Romvimza (vimseltinib) to treat symptomatic TGCT with physical function deterioration in adults for which surgery may lead to functional impairment or severe morbidity Approval was based on P-I/II trial as well as P-III (MOTION) trial, which evaluated Romvimza vs PBO in surgery-ineligible pts without prior anti-CSF1/CSF1R therapy (prior imatinib/nilotinib allowed)…
September 18, 2025

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Merck and Daiichi Sankyo’s Raludotatug deruxtecan Receives FDA’s Breakthrough Therapy Designation for Ovarian, Primary Peritoneal, or Fallopian Tube Cancers 

Shots: The US FDA has granted BTD to Raludotatug deruxtecan (R-DXd) for the treatment of adults with Pt-resistant epithelial ovarian, primary peritoneal or fallopian tube cancers expressing CDH6 who have received prior treatment with Avastin Designation was based on P-I trial (n=179) & the ongoing P-II/III (REJOICE-Ovarian01) trial (n=~710), with subgroup analysis of P-I presented at…
September 16, 2025

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Ionis
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Ionis’ ION582 Receives the US FDA’s Breakthrough Therapy Designation to Treat Angelman Syndrome

Shots: The US FDA has granted BTD to ION582 (UBE3A protein expression stimulant) for the treatment of Angelman syndrome Designation was based on P-I/II (HALOS) trial assessing ION582 in pts with Angelman syndrome, which showed improvements across all functional domains incl. communication, cognition & motor function; safety was favorable Additionally, ION582 is being investigated in…
September 12, 2025

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Eli lilly
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The US FDA Grants Breakthrough Therapy Designation to Eli Lilly’s Olomorasib for KRAS G12C-Mutant NSCLC

Shots: The US FDA has granted BTD to olomorasib + Keytruda for the 1L treatment of pts with unresectable advanced or metastatic NSCLC harboring KRAS G12C mutation & PD-L1 expression ≥ 50% Designation was based on P-I/II (LOXO-RAS-20001) trial of olomorasib monotx. & dose optimization portion from P-III (SUNRAY-01) trial of olomorasib + Keytruda ±…
September 5, 2025

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NEWS

Argo Biopharma Inks a ~$5.3B Deal with Novartis for Multiple Cardiovascular Assets, Expanding their Existing Partnership

Shots: Argo has entered into an additional strategic collaboration with Novartis for multiple CV assets Novartis has obtained an option to license ex-China rights to two discovery-stage molecules for sHTG & mixed dyslipidemia, plus first negotiation rights to BW-00112 (ANGPTL3), a P-II asset. Deal also incl. a reciprocal P&L-sharing license for a hepatic siRNA asset…
September 4, 2025

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Novatim Immune Therapeutics (Keyi Pharmaceutical) Inks a ~$1.16B Licensing Deal with RADIANCE Biopharma for KY-0301 to Treat Cancer

Shots: Novatim has entered into an exclusive global licensing agreement (excl. China) with RADIANCE Biopharma for KY-0301 to treat cancer  As per the deal, RADIANCE Biopharma will receive rights to develop, register, & commercialize KY-0301 globally (excl. China) in exchange for $15M upfront, ~$150M in R&D & registration milestones & ~$1B in commercial milestone, with progressive…
September 3, 2025

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Daiichi Sankyo and Merck Dose First Patient in P-III (HERTHENA-Breast04) Trial of Patritumab Deruxtecan to Treat HR+/HER2- Breast Cancer

Shots: The first patient is dosed in P-III (HERTHENA-Breast04) trial (n=~1000) of patritumab deruxtecan (HER3-DXd; 5.6mg/kg) vs CT/Enhertu for unresectable LA/M, HR+, HER2- breast cancer after progression on endocrine & CDK4/6 inhibitor therapy in either adjuvant or 1L metastatic settings HERTHENA-Breast04 was initiated based on findings from P-II (ICARUS-Breast01) & a P-I/II breast cancer study published…
August 28, 2025

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