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BioWorld - Sunday, February 8, 2026
Home » Topics » Regulatory » IND

IND
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Cancer cells
Cancer

Aprea’s WEE1 inhibitor set to enter phase I for cyclin E-overexpressing cancers

March 12, 2024
Aprea Therapeutics Inc. has received FDA clearance of its IND application for APR-1051, a next-generation inhibitor of WEE1 kinase.
Read More
Test tubes, dropper and capsules
Cancer

Eilean Therapeutics’ menin inhibitor cleared for first-in-human study in Australia

March 12, 2024
Eilean Therapeutics LLC has announced clearance by the Human Research Ethics Committee in Australia for a first-in-human phase I trial of balamenib (ZE63-0302), an oral small-molecule inhibitor of the menin-KMT2A interaction.
Read More
Chinese flag and pills

China NMPA approves 40 innovative new drugs in 2023

March 5, 2024
By Marian (YoonJee) Chu
China’s National Medical Products Administration (NMPA) cleared 40 novel innovative drugs in 2023, of which nearly half were cancer therapies, marking a significant increase from the 21 new class 1 drugs approved in 2022.
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Cancer

Jacobio’s P53 Y220C activator gains FDA clearance to enter clinic for advanced solid tumors

March 1, 2024
Jacobio Pharmaceuticals Group Co. Ltd. has received FDA approval of its IND application for JAB-30300, allowing it begin a phase I/IIa trial in the U.S. in advanced solid tumors.
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Chinese flag and pills

China NMPA approves 40 innovative new drugs in 2023

Feb. 29, 2024
By Marian (YoonJee) Chu
China’s National Medical Products Administration (NMPA) cleared 40 novel innovative drugs in 2023, of which nearly half were cancer therapies, marking a significant increase from the 21 new class 1 drugs approved in 2022.
Read More
3D cross-section illustration of muscle anatomy
Neurology/Psychiatric

Arthex’s ATX-01 receives FDA clearance for first-in-human study in myotonic dystrophy type 1

Feb. 28, 2024
Arthex Biotech SL has received FDA clearance to initiate the phase I/IIa Arthemir study of ATX-01 for the treatment of myotonic dystrophy type 1 (DM1).
Read More
Illustration of head composed of alcoholic beverage glasses
Substance use and poisoning

Clearmind Medicine’s CMND-100 cleared to enter clinic in Israel for alcohol use disorder

Feb. 23, 2024
Clearmind Medicine Inc. has received approval from Israel’s Ministry of Health to initiate a phase I/IIa trial of CMND-100 oral capsules for alcohol use disorder (AUD). The multinational trial in healthy volunteers and AUD subjects will be conducted in Israel and the U.S.
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Microscopic image of acute myeloid leukemia (AML) cells.
Cancer

Kurome’s KME-0584 receives IND clearance for relapsed or refractory AML and high-risk MDS

Feb. 16, 2024
Kurome Therapeutics Inc. has received FDA clearance of its IND for KME-0584.
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SARS-CoV-2 virus particles
Infection

Trawsfynydd’s Mpro inhibitor TRX-01 cleared to begin first-in-human study for COVID-19

Feb. 13, 2024
Trawsfynydd Therapeutics Inc. has received approval to initiate a first-in-man phase I trial of the novel best-in-class COVID-19 treatment, TRX-01, an inhibitor targeting the SARS-CoV-2 viral main protease (3CL, Mpro).
Read More
Test tubes, dropper and capsules
Cancer

Aprea files IND for WEE1 kinase inhibitor

Feb. 7, 2024
Aprea Therapeutics Inc. has submitted an IND application to the FDA to initiate clinical trials of APR-1051, an oral next-generation small-molecule inhibitor of WEE1 kinase.
Read More
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