The U.S. Food and Drug Administration accepted for priority review Pfizer Inc.’s Biologics License Application (BLA) for the 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, as submitted for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults ages 18 years and older.
The U.S. Food and Drug Administration approved BioCryst Pharmaceuticals Inc.’s Orladeyo (berotralstat) for prophylaxis to prevent attacks of hereditary angioedema in adults and young patients 12 years and older.
Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), noted that it would take time – possibly months – before people 18 years of age and younger could get a Covid-19 vaccine because clinical trials were either underway or had not yet begun.
Former U.S. Presidents Barack Obama, George W. Bush and Bill Clinton said they were willing to be vaccinated against the novel coronavirus on television in order to ease any public skepticism over the safety of new vaccines.
The Janssen Pharmaceutical Companies of Johnson & Johnson submitted a Biologics License Application to the U.S. Food and Drug Administration seeking approval of amivantamab for the treatment of patients with metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.
The U.S. Food and Drug Administration gave Emergency Use Authorization (EUA) to a Covid-19 test developed by Roche that measures antibodies within the blood.
AstraZeneca Plc will likely get results of the company’s U.S. Covid-19 vaccine trial in late January 2021 and could potentially file for an emergency authorization, the chief adviser for the U.S. government’s Operation Warp Speed program said.
The U.S. Food and Drug Administration approved Genentech and Blueprint Medicines’ Gavreto (pralsetinib) as a treatment for adults and pediatric patients 12 and older who have been diagnosed with rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC).
The United Kingdom’s Medicines & Healthcare Products Regulatory Agency (MHRA) granted temporary authorization for emergency use to Pfizer and BioNTech for the companies’ mRNA vaccine BNT162b2, marking the first Western country EUA for a Covid-19 vaccine.
Moderna Inc.’s Covid-19 vaccine could be approved for emergency use within 24 to 72 hours after the U.S. health regulator’s advisory committee meeting, Chief Executive Officer Stéphane Bancel said.