The U.S. Food and Drug Administration says that it has granted priority review for the vaccine developed by Pfizer and BioNTech. A decision on whether to fully approve the vaccine will likely be made within two months.
U.S. President Joe Biden signs a 72-point executive order placing tighter regulations and scrutiny on major corporations in a variety of sectors, including Big Tech companies. Policies outlined include banning non-compete clauses, curbing the ability of manufacturers to restrict the right to repair certain products, granting the Federal Trade Commission the ability to set guidelines on data collection, banning unfair competition practices in online marketplaces, and ordering the Food and Drug Administration to work with states and Native American tribal governments on procuring cheaper medicines from Canada.
The U.S. Food and Drug Administration approves Sage Therapeutics' Zulresso, also known as allopregnanolone or brexanolone, for treatment of postpartum depression. It is the first drug approved to specifically target the disease, which is the most common complication of childbirth.
The US Food and Drug Administration approves Janssen Pharmaceutica's esketamine for treatment-resistant depression. The drug is the chemical cousin of ketamine, a powerful anesthetic and recreational drug, and the first major new depression treatment to be approved by the FDA in more than 30 years.
The U.S. Food and Drug Administration asks pharmaceutical manufacturer Endo International plc to withdraw its long-lasting (12 hours) opioid painkiller, Opana ER, from the market after an FDA panel concluded the drug's benefits no longer outweighed the risks of abuse. Endo is evaluating its options.
The U.S. Food and Drug Administration (FDA) approves the country's first biosimilar drug, Zarxio (Europe: 2009, as Zarzio), made by Novartis. Biosimilars are a relatively new class of drugs designed to pave the way for less expensive versions of the complex biologics drug class, and they are not synthesized from chemicals like other drugs, but are made from living cells. Some well known biologics include Remicade and Enbrel for autoimmune diseases, and Herceptin and Avastin for cancer. Zarxio, used to prevent infection in cancer patients receiving chemotherapy, is a close copy of Neupogen, made by Amgen.
The United States Court of Appeals for the Sixth Circuit rules against a First Amendment free speech challenge to a regulation by the Food and Drug Administration requiring that tobacco companies put graphic images on their cigarette packaging. The imagery is designed to discourage smoking.