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1749 News Found

Merck’s Keytruda reduced the risk of death by 38% for patients with RCC
Clinical Trials | January 29, 2024

Merck’s Keytruda reduced the risk of death by 38% for patients with RCC

Keynote -564 is the first Phase 3 trial to demonstrate superior overall survival (OS) with adjuvant therapy compared to placebo in patients with RCC


EMA validates Type II variation application for enfortumab vedotin with pembrolizumab for treatment of bladder cancer
Drug Approval | January 29, 2024

EMA validates Type II variation application for enfortumab vedotin with pembrolizumab for treatment of bladder cancer

Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival


EMA grants ODD to GC Biopharma's treatment for Sanfilippo Syndrome
Drug Approval | January 23, 2024

EMA grants ODD to GC Biopharma's treatment for Sanfilippo Syndrome

GC1130A has previously achieved notable milestones by securing both RPDD and ODD from the U.S. FDA in January 2023


European Commission grants ODD to NS-229 for treatment of Eosinophilic Granulomatosis
Clinical Trials | January 23, 2024

European Commission grants ODD to NS-229 for treatment of Eosinophilic Granulomatosis

The orphan drug designation by the EC is issued for drugs which are intended to treat diseases that affect fewer than five in 10,000 people in the European Union


AbbVie launches Produodopa for treatment of parkinson's disease in EU
News | January 20, 2024

AbbVie launches Produodopa for treatment of parkinson's disease in EU

Produodopa is the first-and-only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of severe motor fluctuations


Zydus and Synthon inks licensing and supply agreement for Palbociclib Tablets for US market
Drug Approval | January 19, 2024

Zydus and Synthon inks licensing and supply agreement for Palbociclib Tablets for US market

Synthon will be responsible for obtaining US regulatory approval for Palbociclib Tablets


NATCO invests US$ 2 million in Cellogen Therapeutics
News | January 18, 2024

NATCO invests US$ 2 million in Cellogen Therapeutics

Both these innovations are aimed at reducing the risk of relapse post CAR T cell therapy


ARTBIO and PharmaLogic inks supply agreement for Lead-212 based Therapeutic Candidate for  treatment of prostate cancer
Supply Chain | January 15, 2024

ARTBIO and PharmaLogic inks supply agreement for Lead-212 based Therapeutic Candidate for treatment of prostate cancer

PharmaLogic will assist ARTBIO with radiochemistry and supply of the finished radiopharmaceutical product for future Phase I and II clinical trials of AB001 from their facility in New York


USFDA accepts sBLA of TIVDAK for priority review for patients with metastatic cervical cancer
Drug Approval | January 10, 2024

USFDA accepts sBLA of TIVDAK for priority review for patients with metastatic cervical cancer

Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy


GSK to acquire Aiolos Bio for US$ 1 billion upfront payment
News | January 10, 2024

GSK to acquire Aiolos Bio for US$ 1 billion upfront payment

Acquisition expands GSK’s respiratory pipeline adding AIO-001, a phase II-ready, long-acting antibody targeting the clinically validated TSLP pathway