Merck announced that the European Medicines Agency (EMA) has validated for review, the application for tepotinib for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations.
ADC Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for loncastuximab tesirine (Lonca) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and granted priority review status
Pfizer and BioNTech are seeking emergency use authorisation (EUA) status from the US Food and Drug Administration (FDA) for their Covid-19 vaccine candidate.
Zymeworks announced that the European Commission (EC) has granted Orphan Drug designation for zanidatamab, the company’s investigational HER2-targeted bispecific antibody, in patients with gastric cancer.
Adaptive Phage Therapeutics (APT) announced clearance by the U.S. Food and Drug Administration (FDA) of the company’s Expanded Access IND for PhageBank treatment for pneumonia or bacteremia/septicemia due to Acinetobacter baumannii, Pseudomonas aeruginosa or Staphylococcus aureus in COVID-19 patients.
AstraZeneca and Daiichi Sankyo's ENHERTU (fam-trastuzumab deruxtecan-nxki) has received acceptance for its supplemental Biologics License Application (sBLA) and has also been granted Priority Review in the US for the treatment of patients with HER2-positive metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Pfizer announced that the U.S. Food and Drug Administration (FDA) accepted for filing and granted Priority Review designation to the company’s New Drug Application (NDA) for abrocitinib (100mg and 200mg), an investigational oral once-daily Janus kinase 1 (JAK1) inhibitor, for the treatment of moderate to severe atopic dermatitis (AD) in patients 12 and older.
Novartis has secured orphan drug designation from the European Medicines Agency (EMA) for its oral, small molecule iptacopan (LNP023) in IgA nephropathy (IgAN).
AstraZeneca’s TAGRISSO (osimertinib) has received acceptance for its supplemental New Drug Application (sNDA) and has also been granted Priority Review in the US for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumor resection with curative intent.
Y-mAbs Therapeutics announced that the U.S. Food and Drug Administration (“FDA”) has cleared the Company’s Investigational New Drug (“IND”) application for 177Lu-omburtamab-DTPA for the treatment of medulloblastoma, which is the most common type of primary brain cancer in children.
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