Regulation

EC approves Vertex’s Symkevi plus Kalydeco to treat CF in children aged 6-11 years

Vertex Pharmaceuticals has secured approval from the European Commission (EC) for Symkevi (tezacaftor/ivacaftor) plus Kalydeco (ivacaftor) for the treatment of elder children with cystic fibrosis (CF) aged between six and 11 years.

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.

Astellas, FibroGen get approval in Japan for Evrenzo to treat anaemia of CKD in adult patients not on dialysis

Astellas Pharma and FibroGen have announced the receipt of approval from the Japan’s Ministry of Health, Labour and Welfare (MHLW) for Evrenzo (roxadustat) to treat anaemia in adult patients suffering from chronic kidney disease (CKD) but not on dialysis.

FDA defers approval of DaxibotulinumtoxinA for Injection in glabellar lines due to Covid-19 related travel restrictions

Revance Therapeutics announced that the United States (U.S.) Food and Drug Administration (FDA) has deferred a decision on the Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection, an investigational neuromodulator product for the treatment of moderate to severe glabellar (frown) lines.

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.

Eli Lilly, Incyte get FDA EUA status for baricitinib plus remdesivir to treat Covid-19

Eli Lilly and Incyte have secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for baricitinib plus remdesivir to treat hospitalised patients with Covid-19.

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.