Offstream
news

The U.S. FDA announces that they have approved the first test to detect COVID-19 through breathing.
2022-04-14

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.
2021-07-16

The U.S. Food and Drug Administration approves the use of aducanumab to treat Alzheimer's disease, the first Alzheimer's drug to be approved in 18 years and the first to target the disease process. The drug is considered controversial as clinical trials gave conflicting results on its effectiveness.
2021-06-7

The Food and Drug Administration authorizes the Pfizer–BioNTech vaccine for use in children between the ages of 12 and 15 years.
2021-05-10

The Food and Drug Administration approves the single-dose Johnson & Johnson vaccine for emergency use in the United States.
2021-02-27

The Food and Drug Administration grants emergency use authorization for Eli Lilly and Company's combination antibody therapy bamlanivimab-etesevimab for use in COVID-19 positive adults and children aged 12 and older who are at high risk of severe disease.
2021-02-9

The U.S. Food and Drug Administration bans the usage of seven artificial flavors as food additives. Six of them cause cancer in animals when used in "much higher" doses than the conditions of their intended use.
2018-10-6

A panel of external experts to the U.S. Food and Drug Administration unanimously vote that the benefits of the gene replacement treatment made by Spark Therapeutics of Philadelphia, Pennsylvania, called voretigene neparvovec (trade name, Luxturna), which treats Leber's congenital amaurosis (LCA), a form of hereditary blindness, outweigh its risks. The treatment, which targets a specific disease-causing mutation, is designed to treat individuals who have two mutated copies of a gene called "RPE65" and consists of a virus injected into the eye loaded with a normal copy of the "RPE65" gene. Further, this technique utilizing adeno-associated virus as a vector may, in the future, be used for the treatment of heart disease and also mutations other than LCA, including some cancers.
2017-10-12

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.
2017-06-8

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.
2015-03-6