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Abbvie
NEWS

AbbVie Reports the US FDA’s BLA Submission of Pivekimab Sunirine to Treat Blastic Plasmacytoid Dendritic Cell Neoplasm

Shots:The US FDA has received BLA of Pivekimab sunirine (PVEK) for the treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)The BLA is backed by the P-I/II (CADENZA) trial, which evaluated PVEK monotx. to establish the MTD, RP2D, & dosing schedule, while assessing safety, tolerability, PK, immunogenicity, & antileukemia activity in pts with CD123+…
October 1, 2025

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Merus
NEWS

Genmab to Acquire Merus for ~$8B

Shots:Genmab has entered into a transaction agreement to acquire Merus, incl. its lead asset petosemtamab, expanding its late-stage pipeline & accelerating Genmab’s shift to a wholly owned modelAs per the deal, Genmab will acquire Merus for $97 per share in an all-cash transaction, representing the deal value of ~$8B, with closing expected in the…
September 29, 2025

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NEWS

Artios’ Alnodesertib Obtains the US FDA’s Fast Track Designation for ATM-negative Metastatic Colorectal Cancer

Shots:The US FDA has granted FTD to alnodesertib + low-dose irinotecan as the 3L treatment of adults with ATM-negative metastatic colorectal cancer (mCRC)Designation was based on the P-I/II (STELLA) trial (ongoing in the US) assessing the regimen in solid tumors with ATM deficiency, which showed responses in 3L mCRC & 7 additional solid…
September 25, 2025

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NEWS

Solid Biosciences & Kinea Bio Partner to Advance KNA-155 Using AAV-SLB101 for Dysferlin-Related Limb-Girdle Muscular Dystrophy

Shots:Solid Biosciences has entered into a non-exclusive global license & collaboration agreement with Kinea Bio to develop & commercialize KNA-155 for treating dysferlin-related limb-girdle muscular dystrophy, using Solid’s AAV-SLB101 capsidAs per the deal, Kinea Bio will receive a non-exclusive global license to utilize AAV-SLB101 for the delivery of KNA-155, which will enter IND-enabling studies…
September 24, 2025

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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 morbidityApproval 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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NEWS

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 AvastinDesignation 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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Akesobio
NEWS

Akeso Reports First Patient Dosing in P-II (COMPASSION-36) Trial of Cadonilimab for PD-1 Treatment-Resistant Hepatocellular Carcinoma (HCC)

Shots:Akeso has dosed its first patient with cadonilimab + lenvatinib in P-II (COMPASSION-36/AK104-225) trial against lenvatinib for the treatment of advanced HCC in pts previously treated with Tecentriq & Avastin; study is ongoing in the US, EU & ChinaCadonilimab has also shown superior efficacy in combination regimens, incl. 100% DCR with FOLFOX-HAIC in resectable multinodular HCC…
September 15, 2025

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