News about Drug Discovery & Development

Dupixent Approval in Japan Boosts Biologics Manufacturing Demand for Sanofi and Regeneron

Dupixent Approval in Japan Boosts Biologics Manufacturing Demand for Sanofi and Regeneron

The Ministry of Health, Labour and Welfare has granted marketing and manufacturing authorization to Dupixent (dupilumab) for the treatment of adults with moderate-to-severe bullous pemphigoid (BP), a rare and debilitating skin disorder.

Drug Discovery & Development | 25/03/2026 | By Darshana 119

Biotheryx Doses First Patient in Dose Expansion Trial of BTX-9341 for Advanced Breast Cancer

Biotheryx Doses First Patient in Dose Expansion Trial of BTX-9341 for Advanced Breast Cancer

Biotheryx advances BTX-9341 into a dose expansion trial with fulvestrant for HR+/HER2- breast cancer, aiming to overcome resistance in patients previously treated with CDK4/6 inhibitors.

Drug Discovery & Development | 19/03/2026 | By News Bureau 106

US FDA Pushes Shift Away from Animal Testing in Early Drug Studies

US FDA Pushes Shift Away from Animal Testing in Early Drug Studies

The U.S. Food and Drug Administration (FDA) is pushing for a shift away from animal testing in early-stage drug development, encouraging companies to adopt more modern and human-relevant methods.

Drug Discovery & Development | 19/03/2026 | By Darshana 122

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

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 112

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

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 172

KORU Medical Gains EU MDR Approval For Freedom60 Infusion Pump

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 109

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

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

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

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 101

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

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 108

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

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

 
 

 

 

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