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PD-L1 IHC 22C3 pharmDx gains CE-marked indication to identify eligible patients with epithelial ovarian, fallopian tube and primary peritoneal carcinoma for pembrolizumab treatment.
Quality / GMP | 27/07/2026 | By News Bureau
EU Approves AstraZeneca's Etcamah Combination for ESR1-Mutated Advanced Breast Cancer
The European Commission has approved AstraZeneca’s Etcamah in combination with CDK4/6 inhibitors for ESR1-mutated ER-positive, HER2-negative advanced breast cancer, following Phase 3 data demonstrating a 56% reduction in the risk of disease progression or death.
Quality / GMP | 24/07/2026 | By News Bureau
FDA Grants Priority Review to Pfizer's Talzenna-Xtandi Combination Advanced Prostate Cancer
Pfizer’s Talzenna-Xtandi combination receives FDA Priority Review for HRR gene-altered metastatic castration-sensitive prostate cancer, with Phase 3 data demonstrating a 52 percent reduction in the risk of disease progression or death.
Quality / GMP | 24/07/2026 | By News Bureau
Chiesi Secures UK Approval for World's First Low-Carbon pMDIs Using Next-Generation Propellant
MHRA authorises Clenil Modulite inhalers with a non-PFAS, low global warming potential propellant, reducing carbon emissions by up to 90 percent while maintaining therapeutic efficacy.
Quality / GMP | 23/07/2026 | By News Bureau
JCR Pharmaceuticals secures its first international approval for Izcargo in the UAE, expanding access to its innovative blood-brain barrier-penetrating therapy for patients with Hunter syndrome and advancing rare disease treatment across the MENA region.
Quality / GMP | 23/07/2026 | By News Bureau
Dyne Therapeutics' Duchenne Muscular Dystrophy Therapy Receives FDA Priority Review
FDA accepts Biologics License Application for investigational exon 51-skipping therapy z-rostudirsen, with a regulatory decision expected by January 2027.
Quality / GMP | 22/07/2026 | By News Bureau
CuraTeQ Biologics Secures ANVISA Approval for Hyderabad Biosimilars Manufacturing Facility
CuraTeQ Biologics has received ANVISA GMP approval for its Hyderabad biosimilars manufacturing facility, strengthening its global regulatory credentials and enabling expanded supply of biosimilar products to Brazil and the wider Latin American market.
Quality / GMP | 22/07/2026 | By News Bureau | 155
Can-Fite BioPharma Secures Australian Patent for Namodenoson in Advanced Metastatic Cancer
Can-Fite BioPharma has secured an Australian patent covering the use of Namodenoson for advanced metastatic cancer, strengthening intellectual property protection as the drug advances through late-stage clinical development for liver and pancreatic cancers.
Quality / GMP | 15/07/2026 | By News Bureau
TolerogenixX Secures EU Orphan Drug Designation for MIC-Lx in Living-Donor Kidney Transplantation
European Commission grants orphan status to Tolerogenix’s personalized cell therapy following EMA recommendation, strengthening its regulatory pathway alongside recent PRIME designation.
Quality / GMP | 14/07/2026 | By News Bureau
China Grants Priority Review to Leads Biolabs' Opamtistomig for Advanced Neuroendocrine Carcinoma
NMPA accepts biologics license application under expedited review pathway for investigational PD-L1/4-1BB bispecific antibody targeting advanced extrapulmonary neuroendocrine carcinoma after multiple prior therapies.
Quality / GMP | 13/07/2026 | By News Bureau | 108
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