The U.S. Centers for Disease Control and Prevention (CDC) on Sept. 24 backed a booster shot of the Pfizer and BioNTech Covid-19 vaccine for Americans aged 65 and older, adults with underlying medical conditions and adults in high-risk working and institutional settings.
The U.S. Food and Drug Administration on Sept. 21 approved Incyte Corp.’s cream Opzelura for treating the inflammatory skin condition atopic dermatitis, commonly called eczema, in adolescents and adults with boxed warnings.
Advisers to the U.S. Food and Drug Administration voted on Sept. 17 to recommend Covid-19 vaccine booster shots for Americans 65 and older and those at high risk of severe illness, after overwhelmingly rejecting a call for broader approval.
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.
Johnson & Johnson said the company’s Ebola vaccine regimen demonstrated antibody immune responses in adults and children, citing data published in the Lancet Infectious Diseases journal.
Researchers from the Karolinska Institute in Sweden and University Children’s Hospital, Ruhr-University-Bochum, Germany, studied the impact of Covid-19 infections on lung function.
Heading into fall, with the Covid-19 pandemic surging again and researchers tracking new variants, there is plenty of news. BioSpace takes a look, including several research studies suggesting that some people have unusually strong immunity against Covid-19.
In MacroGenics’ SOPHIA Phase III study in adults with metastatic HER2-positive breast cancer, the biopharmaceutical company’s Margenza plus chemotherapy failed to show a statistically significant advantage when compared to trastuzumab plus chemotherapy in the intent-to-treat population.
75 percent of adults in the United States have received at least one dose of a Covid-19 vaccine as of the morning of Sept. 7, the U.S. Centers for Disease Control and Prevention said.
BeiGene Ltd.’s Brukinsa (zanubrutinib) received approval from the U.S. Food and Drug Administration for the treatment of adult patients with Waldenström’s macroglobulinemia (WM).