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 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.
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 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.
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.
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.
Specialist HIV company ViiV Healthcare has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its long-acting and injectable cabotegravir to treat HIV pre-exposure prophylaxis (PrEP).
Amylyx Pharmaceuticals, a pharmaceutical company focused on developing new treatments for amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and other neurodegenerative diseases, announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to AMX0035 for the treatment of Wolfram syndrome.
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