The European Medicines Agency (EMA) has validated two marketing authorization applications (MAAs) for Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan (Dato-DXd) for two types of cancer.
The US Food and Drug Administration (FDA) has granted orphan drug designation to SN Bioscience's SNB-101, a polymer nanoparticle anticancer drug to potentially treat pancreatic cancer.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided positive opinion for the Janssen Pharmaceutical Companies of Johnson & Johnson’s CARVYKTI (cilta-cel) for earlier stage of relapsed and refractory multiple myeloma (RRMM) treatment.
Japan's Ministry of Health, Labour and Welfare (MHLW) has granted priority review for Astellas Pharma’s supplemental new drug application (sNDA) for PADCEV (enfortumab vedotin) and KEYTRUDA (pembrolizumab) combination to treat urothelial cancer.
Clinical-stage biotechnology company ProfoundBio has secured $112m in a Series B financing round to advance its clinical-stage antibody-drug conjugate (ADC) pipeline for cancer treatment.
Contract development and manufacturing organization (CDMO) Samsung Biologics has entered into a strategic partnership with LegoChem Biosciences to advance antibody-drug conjugate (ADC) programmes aimed at treating solid tumours.
Asian healthcare solutions company Zuellig Pharma has concluded the acquisition of Cialis (Tadalafil) and Alimta (Pemetrexed) brands from Eli Lilly and Company.
The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for South Korean biopharmaceutical company Rznomics’ RZ-001 to treat hepatocellular carcinoma (HCC).
NeoImmuneTech, a company specialising in T cell-focused therapeutics, has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its NT-I7 (efineptakin alfa) (rhIL-7-hyFc), for the treatment of pancreatic cancer.
The European Medicines Agency (EMA) has validated for review a Type II variation application for Pfizer and Astellas Pharma’s PADCEV (enfortumab vedotin) with KEYTRUDA (pembrolizumab) as first-line therapy option for locally advanced or metastatic urothelial cancer (la/mUC).
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