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11

FDA revises Lilly’s COVID-19 antibody combo EUA for use after exposure to virus

The U.S. Food and Drug Administration said on Sept. 16 it has revised the FDA’s emergency use authorization for Eli Lilly’s Covid-19 antibody cocktail to include for use in patients who have been exposed to the virus and are at high risk for progression to severe disease.

17

Takeda’s Exkivity Approved by U.S. FDA as First Oral Therapy Specifically Designed for Patients with EGFR Exon20 Insertion+ NSCLC

The U.S. Food and Drug Administration approved Takeda Pharmaceutical Company Limited’s Exkivity (mobocertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

19

FDA staff say Pfizer COVID-19 boosters may not be needed, but do improve immunity

U.S. Food and Drug Administration scientists said on Sept. 15 that booster doses of Pfizer’s Covid-19 vaccine may not be needed, even though the third shot generates a higher immune response in recipients.

20

Study: Survivors of Severe COVID-19 at Risk for Autoimmune Disease

A study published in Nature Communications reveals that patients who had been hospitalized with severe Covid-19 might not be totally safe after recovery, as they are more likely to harbor self-attacking antibodies than those who did not have the virus.