News about Drug Discovery & Development

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 144

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 145

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 148

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

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 152

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

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 240

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

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 137

Merck reports positive Phase III results for Keytruda and Welireg combination in kidney cancer

Merck reports positive Phase III results for Keytruda and Welireg combination in kidney cancer

Phase III LITESPARK-022 trial shows Keytruda plus Welireg significantly improves disease-free survival in patients with clear cell renal cell carcinoma after surgery, reducing recurrence or death risk by 28 percent.

Drug Discovery & Development | 05/03/2026 | By News Bureau 174

Ipsen receives positive EMA panel opinion for Ojemda to treat paediatric low-grade glioma

Ipsen receives positive EMA panel opinion for Ojemda to treat paediatric low-grade glioma

European Medicines Agency’s CHMP recommends conditional approval of Ojemda (tovorafenib) for children with BRAF-altered paediatric low-grade glioma, offering a potential targeted therapy option for relapsed or refractory cases.

Drug Discovery & Development | 05/03/2026 | By News Bureau 232

EMA Panel Backs Norgine?s XOLREMDI for WHIM Syndrome Under Exceptional Circumstances

EMA Panel Backs Norgine?s XOLREMDI for WHIM Syndrome Under Exceptional Circumstances

The EMA’s CHMP recommends marketing authorisation for XOLREMDI (mavorixafor) to treat WHIM syndrome patients aged 12 and above, marking a major step toward the first licensed therapy for the rare disorder.

Drug Discovery & Development | 03/03/2026 | By News Bureau 165

XellSmart Secures Fourth FDA and NMPA Clearance for iPSC-Derived Cell Therapy Targeting MSA-P

XellSmart Secures Fourth FDA and NMPA Clearance for iPSC-Derived Cell Therapy Targeting MSA-P

XellSmart receives US FDA and China NMPA clearance for Phase I/II trials of its iPSC-derived neuron progenitor therapy for MSA-P, expanding its CNS pipeline spanning PD, ALS and spinal cord injury.

Drug Discovery & Development | 03/03/2026 | By News Bureau 264

 
 

 

 

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