News about Drug Discovery & Development

NIH-Supported Trial Finds Weekly Injectable Buprenorphine More Effective for Opioid Use Disorder in Pregnancy

A National Institutes of Health-backed study shows weekly injectable buprenorphine improves opioid abstinence and reduces serious risks compared to sublingual treatment in pregnant women with opioid use disorder.

Drug Discovery & Development | 18/03/2026 | By News Bureau |  175

Shanghai UniXell Biotechnology Secures US FDA IND Clearance for UX-GIP001, First iPSC-Derived Cell Therapy for Epilepsy

Shanghai UniXell Biotechnology. has received US Food and Drug Administration IND clearance for UX-GIP001, marking the first iPSC-derived allogeneic cell therapy to enter clinical trials for Epilepsy in the US.

Drug Discovery & Development | 17/03/2026 | By News Bureau |  273

KORU Medical Gains EU MDR Approval For Freedom60 Infusion Pump

KORU Medical Systems has announced that its Freedom60 Infusion Pump, including the adapter designed for use with 50 mL prefilled syringes, has received certification under the European Union Medical Devices Regulation (EU MDR 2017/745). The certification allows the company to commercialise the device across the European Union.

Drug Discovery & Development | 16/03/2026 | By Darshana |  171

Cbio A/S Secures Regulatory Clearance for First-in-Human Trial of Novoleucel T-Cell Therapy for Cervical Cancer

Cbio A/S has received regulatory approval to begin a Phase I/IIa trial of novoleucel, a next-generation T-cell therapy, in patients with recurrent Cervical Cancer.

Drug Discovery & Development | 16/03/2026 | By News Bureau |  213

Hutchmed Initiates Tazverik Recall In China After Ipsen Withdraws Drug In US

Hutchmed (China) Limited has begun withdrawing the cancer therapy Tazverik (tazemetostat) from markets in mainland China, Hong Kong and Macau after its partner Ipsen decided to voluntarily remove the drug from the US market.

Drug Discovery & Development | 11/03/2026 | By Darshana |  160

Citius Oncology Reports Positive Phase I Results for LYMPHIR- Keytruda Combination in Gynecologic Cancers

Citius Oncology reports positive Phase I data showing encouraging safety and response rates for LYMPHIR combined with Keytruda in recurrent gynecologic cancers, supporting further Phase II evaluation.

Drug Discovery & Development | 11/03/2026 | By News Bureau |  168

Harbour BioMed and Kelun-Biotech Secure National Medical Products Administration IND Approval for Novel Bispecific Antibody in Atopic Dermatitis

National Medical Products Administration approves IND application for HBM7575/SKB575, a long-acting bispecific antibody developed by Harbour BioMed and Kelun-Biotech for treating atopic dermatitis.

Drug Discovery & Development | 10/03/2026 | By News Bureau |  182

AstraZeneca and Daiichi Sankyo Secure US Food and Drug Administration Priority Review for Enhertu in HER2-Positive Breast Cancer

US Food and Drug Administration grants Priority Review to supplemental application for Enhertu to treat HER2-positive breast cancer patients with residual disease after neoadjuvant therapy, with decision expected in Q3 2026.

Drug Discovery & Development | 10/03/2026 | By News Bureau |  180

Insilico Medicine's AI-Discovered CKD Anemia Drug ISM4808 Enters Phase I Trial Under TaiGen Biotechnology Partnership

TaiGen Biotechnology doses first participant in Phase I trial of ISM4808, an AI-designed oral therapy from Insilico Medicine for chronic kidney disease-related anemia.

Drug Discovery & Development | 09/03/2026 | By News Bureau |  286

U.S. Food and Drug Administration Approves Tec-Dara Combination Therapy for Relapsed Multiple Myeloma

U.S. Food and Drug Administration grants rapid approval to Tec-Dara, a combination of teclistamab and daratumumab hyaluronidase-fihj, for adults with relapsed or refractory multiple myeloma after at least one prior therapy.

Drug Discovery & Development | 07/03/2026 | By News Bureau |  164