The Centers for Disease Control and Prevention gave the go-ahead for the use of Moderna’s and Janssen’s Covid-19 vaccines as booster shots six months and two months, respectively, after their initial series as well as the approval of mixing and matching vaccines.
The Pfizer/BioNTech Covid-19 vaccine showed 90.7 percent efficacy against the coronavirus in a clinical trial of children 5 to 11 years old, the U.S. drugmaker said on Oct. 22.
Nearly four months after Intellia Therapeutics – along with partner Regeneron Pharmaceuticals – reinvigorated the CRISPR space with the first-ever clinical evidence that CRISPR gene editing inside the body can be safe and effective, the asset in question was granted Orphan Drug Designation by the U.S. Food and Drug Administration.
A trial assessing an experimental AstraZeneca cancer drug was placed on clinical hold due to safety concerns. The trial pause comes two years after Amgen was also forced to pause a study of a drug within the same class.
A booster dose of the Covid-19 vaccine developed by Pfizer Inc. and German partner BioNTech SE restored efficacy to 95.6 percent against the virus, including the Delta variant, data released by the companies from a large study showed on Oct. 21.
The U.S. Food and Drug Administration on Oct. 20 authorized booster doses of the Covid-19 vaccines from Moderna Inc. and Johnson & Johnson, and the regulatory agency said Americans can choose a different shot from their original inoculation as a booster.
Shares in Adamis Pharmaceuticals rose 31 percent on Oct. 18 on news that the U.S. Food and Drug Administration approved the company’s naloxone injection Zimhi for the treatment of opioid overdose. This was Adamis’ third attempt to have the drug approved, following two CRLs.
The U.S. Food and Drug Administration is planning to allow Americans to get a different booster shot of a Covid-19 vaccine than the one initially taken, the New York Times reported on Oct. 18.
The U.S. Food and Drug Administration greenlit a new indication for Gilead Sciences’ drug Biktarvy for pediatric patients with HIV who are virologically suppressed or new to antiretroviral therapy.
Omeros, MannKind-United Therapeutics, and Revance Therapeutics were issued Complete Response Letters from the U.S. Food and Drug Administration.