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May 07, 2020
Tabrecta is approved to specifically target metastatic non-small cell lung cancer with a mutation that leads to MET exon 14 skipping (METex14).
May 02, 2020
FDA’s EUA provides the first new treatment for COVID-19 patients with severe symptoms.
April 30, 2020
The approval was based on pharmacokinetic data, the relationship of exposure to efficacy, and the relationship of exposure to safety.
April 23, 2020
The approval was based off of positive results from a Phase III study that showed patients 70 years or younger treated with the BTK inhibitor lived longer without disease progression.
April 10, 2020
The guidance answers questions on changes made to the regulatory framework to address challenges during the COVID-19 pandemic.
April 08, 2020
EMA's CHMP has recommended the use of remdesivir, an investigational antiviral medicine, in compassionate use programs across the European Union.
April 02, 2020
FDA is encouraging alternative insulins and challenging anticompetitive practices.
Specialty pharmaceutical company, Diurnal, has announced that the marketing authorization application (MAA) for Chronocort has passed validation with the European Medicines Agency (EMA).
April 01, 2020
The patent includes the use of fibroblast cells and adjuvants such as peptides and hydroxychloroquine, which fuels the assembly of natural interferon to overpower the virus.
March 27, 2020
AstraZeneca has announced that it has achieved approval in Japan for Lokelma (sodium zirconium cyclosilicate) for the treatment of patients with hyperkalemia (elevated blood potassium levels).