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

Amgen Acquires Dark Blue Therapeutics for ~$840M

Shots: Amgen has acquired Dark Blue Therapeutics, strengthening its early oncology discovery efforts & pipeline As per the deal, Amgen acquired Dark Blue Therapeutics in a transaction valued at ~$840M, integrating Dark Blue into its existing research organization Acquisition will add a preclinical small molecule that degrades MLLT1/3 in select acute myeloid leukemia subtypes, showing differentiated anti-cancer activity…

ByRidhi RastogiJanuary 7, 2026

NEWS

Kura Oncology and Kyowa Kirin Report the US FDA’s Approval Komzifti (Ziftomenib) for NPM1-Mutated Acute Myeloid Leukemia (AML)

Shots: The US FDA has granted full approval to Komzifti (QD, PO) to treat adults with r/r AML with NPM1 mutation who have no satisfactory alternative treatment options before the PDUFA date of Nov 30, 2025 Approval was backed by P-I/II (KOMET-001) trial in 112 r/r NPM1-mutant AML pts, showing 21.4% CR + CRh with a median…

ByRidhi RastogiNovember 14, 2025

NEWS

Syndax Pharmaceuticals’ Revuforj (Revumenib) Receives the US FDA’s Approval for NPM1-Mutated R/R Acute Myeloid Leukemia

Shots: The US FDA has approved label expansion of Revuforj to treat pts (≥1yrs.) with nucleophosmin 1 (NPM1)-mutated r/r acute myeloid leukemia (AML) who have no satisfactory alternative treatment options Approval was supported by P-II results from the P-I/II (AUGMENT-101) trial, which showed a 23% CR + CRh rate (15/65), median response time of 2.8mos.,…

ByRidhi RastogiOctober 28, 2025

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+…

ByRidhi RastogiOctober 1, 2025

NEWS

Taiho Oncology (Part of Taiho Pharmaceutical) Reports the US FDA’s sNDA Acceptance of Inqovi + Venetoclax for Newly Diagnosed AML

Shots: The US FDA has accepted sNDA of Inqovi (decitabine & cedazuridine) + venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) pts, ineligible for intensive induction CT (PDUFA: Feb 25, 2026) sNDA was backed by P-IIb (ASCERTAIN-V) trial in 101 adults with newly diagnosed AML ineligible for intensive induction CT, where pts…

ByRidhi RastogiJuly 10, 2025

NEWS

Kura Oncology and Kyowa Kirin Report the US FDA’s NDA Acceptance and Priority Review of Ziftomenib for Acute Myeloid Leukemia

Shots: The US FDA has accepted NDA & granted priority review seeking full approval of ziftomenib to treat adults with r/r acute myeloid leukemia (AML) with NPM1 mutation (PDUFA: Nov 30, 2025) NDA is supported by P-II (KOMET-001) trial assessing ziftomenib in r/r NPM1-mutant AML pts, which met its 1EP of CR & CR with…

ByRidhi RastogiJune 2, 2025

NEWS

Oryzon Reports Dosing of the First Patient with Iadademstat + Venetoclax + Azacitidine in P-I Trial to Treat 1L Acute Myeloid Leukemia (AML)

Shots: The first patient was dosed with iadademstat (ORY-1001) + venetoclax + azacitidine combination to treat AML naïve patients (n=45) under the P-I trial to evaluate the safety, tolerability, preliminary efficacy & optimal dose. Trial will be managed & funded by NCI under CRADA In addition, the combination is being evaluated to treat 1L…

ByDipanshu DixitJanuary 14, 2025

INSIGHTS+

New Drug Designations – August 2023

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, the EU, Japan, and China. This month’s report includes 8 biological drugs, 13 small molecules, 4 cell and gene therapies, 3 diagnostic tests and 5 devices Genprex’ Reqorsa, focused on the treatment of SCLC, is the drug to receive ODD…

BySenior EditorSeptember 18, 2023

INSIGHTS+

Insights+: The US FDA New Drug Approvals in July 2023

Shots: The US FDA approved 5 NDAs and 2 BLA in July 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 76 novel products in 2023 In July 2023, the major highlights drugs were Beyfortus (nirsevimab) approval for the prevention of RSV lower respiratory tract disease in…

BySenior EditorAugust 16, 2023

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

Amgen Acquires Dark Blue Therapeutics for ~$840M

Kura Oncology and Kyowa Kirin Report the US FDA’s Approval Komzifti (Ziftomenib) for NPM1-Mutated Acute Myeloid Leukemia (AML)

Syndax Pharmaceuticals’ Revuforj (Revumenib) Receives the US FDA’s Approval for NPM1-Mutated R/R Acute Myeloid Leukemia

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

Taiho Oncology (Part of Taiho Pharmaceutical) Reports the US FDA’s sNDA Acceptance of Inqovi + Venetoclax for Newly Diagnosed AML

Kura Oncology and Kyowa Kirin Report the US FDA’s NDA Acceptance and Priority Review of Ziftomenib for Acute Myeloid Leukemia

Oryzon Reports Dosing of the First Patient with Iadademstat + Venetoclax + Azacitidine in P-I Trial to Treat 1L Acute Myeloid Leukemia (AML)

New Drug Designations – August 2023

Insights+: The US FDA New Drug Approvals in July 2023

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