Ipsen Receives US FDA Breakthrough Therapy Designation for IPN60340 in Unfit Acute Myeloid Leukemia

Shots: The US FDA has granted Breakthrough Therapy Designation (BTD) to Ipsen’s investigational therapy IPN60340 (ICT01) in combination with venetoclax and azacitidine for the treatment of 1L unfit acute myeloid leukemia (AML) The designation was supported by data from the P-I/II (EVICTION) study (n=57), where IPN60340 + Ven-Aza showed encouraging response rates, including a near…

ByPrince GiriJanuary 14, 2026

NEWS

Sentynl Therapeutics Reports US FDA Approval of Zycubo to Treat Pediatric Menkes Disease

Shots: The US FDA has approved Zycubo (copper histidinate) for the treatment of pediatric patients with Menkes disease Approval was supported by clinical data showing improved OS with early Zycubo treatment vs an untreated external control, reflecting ~80% reduction in the risk of death & a mOS of 177.1 vs 17.6mos. Zycubo is a bioavailable…

ByRidhi RastogiJanuary 14, 2026

INSIGHTS+

The US FDA New Drug Approvals in December 2025

Shots: Innovation peaked in December 2025, as the FDA delivered a wave of approvals spanning cardiometabolic disease, infectious disease, respiratory immunology, rare hematologic disorders, and acute cardiovascular and neurologic conditions highlighting both scientific breadth and clinical precision Seven notable therapies crossed the regulatory finish line, including LIB Therapeutics’ Lerochol for LDL lowering, Innoviva’s Nuzolvence for gonorrhea, GSK’s Exdensur for asthma with eosinophilic phenotype, Cytokinetics’ Myqorzo…

ByDipanshu DixitJanuary 13, 2026

NEWS

Summit Therapeutics Reports the US FDA’s BLA Submission for Ivonescimab to Treat EGFRm Non-Squamous NSCLC

Shots: The US FDA has received BLA of ivonescimab + CT for ≥2L treatment of pts with EGFR-mutated locally advanced or metastatic non-squamous NSCLC; decision is expected by Q4’26 BLA was supported by P-III (HARMONi) trial assessing ivonescimab + Pt-doublet CT vs PBO + Pt-doublet CT in pts with EGFR-mutated, locally advanced or metastatic NSCLC…

ByRidhi RastogiJanuary 13, 2026

NEWS

Shanghai Henlius Reports the US FDA’s BLA Acceptance for HLX04 (Biosimilar, Avastin)

Shots: The US FDA has accepted the BLA for HLX04, a biosimilar version of Avastin (bevacizumab) BLA was supported by analytical similarity studies, a P-I PK comparability trial in healthy subjects, and a multicenter P-III trial in pts with metastatic colorectal cancer, evaluating HLX04 vs the reference product for safety, PK, and immunogenicity Henlius is advancing a P-II/III trial of HLX04 + serplulimab for 1L…

ByDipanshu DixitJanuary 13, 2026

NEWS

Merck KGaA Reports US FDA’s NDA Acceptance of Pimicotinib for Tenosynovial Giant Cell Tumor (TGCT)

Shots: The US FDA has accepted the NDA of Merck KGaA's Pimicotinib (PO) for the systemic treatment of adults with TGCT following NMPA approval NDA was based on the global 3-part P-III (MANEUVER) trial in TGCT pts who require systemic therapy & have not received prior anti-CSF-1/CSF-1R therapy, in which Part 1 randomized 94 pts…

ByRidhi RastogiJanuary 13, 2026

NEWS

RefleXion Medical Reports the US FDA Clearance of RefleXion X2 Platform for Improved Tumor Detection

Shots: The US FDA has cleared RefleXion X2 with SCINTIX therapy for the treatment of primary & metastatic lung & bone tumors X2 platform provides a 20-fold increase in PET sensitivity, increasing detectable biological signal levels for tumor imaging & potentially broadening the population eligible for SCINTIX therapy based on imaging criteria Its wide field-of-view PET detector…

ByRidhi RastogiJanuary 9, 2026

NEWS

Foresee Pharmaceuticals Licenses MMP-12 Inhibitor Programs to Primevera Therapeutics in a ~$584.5M Deal

Shots: Foresee has entered into an exclusive global licensing agreement with Primevera for its MMP-12 inhibitor programs, which incl. FP-025, FP-020 & third-generation MMP-12 inhibitors in discovery stage As per the deal, Foresee USA will receive a $10M upfront, ~$574.5M in milestones, & tiered single-digit royalties, or alternatively a tiered share of sublicense proceeds in lieu…

ByRidhi RastogiJanuary 8, 2026

NEWS

Takeda and Protagonist Therapeutics Report the US FDA’s NDA Submission for Rusfertide to Treat Polycythemia Vera

Shots: The US FDA has received an NDA of rusfertide (SC) for the treatment of adults with polycythemia vera (PV) NDA was followed by 32wk. primary analysis & 52wk. data from the global P-III (VERIFY) trial (n=293) as well as P-II (REVIVE) study, where VERIFY met its 1EP & all key 2EPs, showing higher response…

ByRidhi RastogiJanuary 6, 2026

NEWS

Sanofi Reports the US FDA Priority Review of Tzield to Delay Progression of Type 1 Diabetes in Children (≥1years)

Shots: The US FDA has accepted sBLA & granted priority review to Tzield (teplizumab-mzwv) to delay of the onset of stage 3 T1D in pts (≥1yr.) diagnosed with stage 2 T1D (PDUFA: Apr 29, 2026) sBLA was supported by an interim 1yr. data from the ongoing P-IV (PETITE-T1D) trial assessing the safety & PK of…

ByRidhi RastogiJanuary 5, 2026

Ipsen Receives US FDA Breakthrough Therapy Designation for IPN60340 in Unfit Acute Myeloid Leukemia

Sentynl Therapeutics Reports US FDA Approval of Zycubo to Treat Pediatric Menkes Disease

The US FDA New Drug Approvals in December 2025

Summit Therapeutics Reports the US FDA’s BLA Submission for Ivonescimab to Treat EGFRm Non-Squamous NSCLC

Shanghai Henlius Reports the US FDA’s BLA Acceptance for HLX04 (Biosimilar, Avastin)

Merck KGaA Reports US FDA’s NDA Acceptance of Pimicotinib for Tenosynovial Giant Cell Tumor (TGCT)

RefleXion Medical Reports the US FDA Clearance of RefleXion X2 Platform for Improved Tumor Detection

Foresee Pharmaceuticals Licenses MMP-12 Inhibitor Programs to Primevera Therapeutics in a ~$584.5M Deal

Takeda and Protagonist Therapeutics Report the US FDA’s NDA Submission for Rusfertide to Treat Polycythemia Vera

Sanofi Reports the US FDA Priority Review of Tzield to Delay Progression of Type 1 Diabetes in Children (≥1years)

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