Shares of Humanigen plunged in trading after the company announced the U.S. Food and Drug Administration rejected the company’s Emergency Use Authorization request for lenzilumab, a potential treatment for Covid-19.
Phathom Pharmaceuticals Inc. submitted two new drug applications (NDAs) to the U.S. Food and Drug Administration for the use of vonoprazan in combination with amoxicillin and clarithromycin (vonoprazan triple therapy) and vonoprazan in combination with amoxicillin (vonoprazan dual therapy) as a treatment for Helicobacter pylori infection in adults.
The U.S. Food and Drug Administration placed a clinical hold on BioMarin Pharmaceutical’s BMN 307 Phearless Phase I/II study.
U.S. lawmakers requested data and documents from the Food and Drug Administration related to the regulatory agency’s accelerated approval of Biogen Inc.’s new Alzheimer’s drug, mounting further pressure on the FDA that has come under fire for clearing Aduhelm.
A study published in The Lancet Infectious Diseases found that the Pfizer-BioNTech, Oxford-AstraZeneca or Moderna vaccines resulted in a drop in “long-haul” Covid-19 by 50 percent. According to data collected by the American Academy of Pediatrics (AAP), more than 500,000 children tested positive in the United States for Covid-19 from August 5 to August 26.
Shared in Mesoblast dropped on the last day of August 2021 after the Melbourne-based biotech was told that the company’s investigational respiratory treatment for Covid-19 needed to undergo another trial in order to receive emergency use authorization (EUA) from U.S. Food and Drug Administration.
The U.S. drug regulator asked Pfizer, Eli Lilly and AbbVie to include information about the risks of serious conditions and death from the use of their drugs that belong to a class of treatments known as JAK inhibitors.
Moderna Inc. on Sept. 1 asked the U.S. Food and Drug Administration to allow the use of a third booster dose of the company’s Covid-19 vaccine.
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).
The U.S. Food and Drug Administration greenlit Janssen’s long-acting, twice-per-year schizophrenia drug Invega Hafyera (paliperidone palmitate six-month).
