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Amgen believes this submission is the first adalimumab biosimilar application submitted to the FDA and represents Amgen’s first BLA submission using the 351(k) biosimilar pathway. Amgen executive vice

The approval was based on data the Phase III coBRIM study, which demonstrated that Cotellic plus Zelboraf helped people with previously untreated BRAF V600 mutation-positive advanced melanoma live

The drug’s earlier indication was for the second-line treatment of NSCLC. The data supporting the expanded label was generated by the Phase 3 Profile 1014 study. The study

GCA is characterized by the inflammation of large and medium-sized arteries, mostly in the head and neck, which occurs in people aged 50 or older. Under the study,

Allergan paid Rugen an upfront fee as per the deal but did not disclose the financial details of the research collaboration. The company could pay Rugen additional money

Adaptimmune is developing the affinity enhanced T-cell therapy targeting NY-ESO-1 under a collaboration agreement with GlaxoSmithKline (GSK). Adaptimmune chief medical officer Rafael Amado said: "Lung cancer is the

The application submitted for the treatment of primary immunodeficiency diseases (PID), a class of inherited genetic disorders that causes an individual to have a deficient or absent immune

The acquisition includes parts of the site featuring various new manufacturing units for sterile injectables that are not currently operational. Hikma will retain the remaining plants including the

Indivior received a complete response letter from the FDA focusing on clinical pharmacology that found the early stage uptake of naloxone nasal spray did not fully meet the