Drug Filing

EMA validates application for Tepotinib for treatment of advanced NSCLC with METex14 skipping alterations

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 secures FDA priority review for Lonca in diffuse large B-cell lymphoma

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, BioNTech seek FDA EUA status for Covid-19 vaccine

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 gets EC’s orphan drug designation for zanidatamab in patients with gastric cancer

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.

FDA clears expanded access IND for APT’s PhageBank therapy for Covid-19-related bacterial infections

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.

ENHERTU gets FDA priority review in HER2-positive metastatic gastric cancer

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.

FDA grants priority review and EMA accepts regulatory submission for Pfizer’s abrocitinib

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’ iptacopan gets EMA’s orphan drug designation in IgAN

Novartis has secured orphan drug designation from the European Medicines Agency (EMA) for its oral, small molecule iptacopan (LNP023) in IgA nephropathy (IgAN).

TAGRISSO granted FDA priority review in early-stage EGFR-mutated lung cancer

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.