FDA temporarily bans the use of monoclonal antibodies to treat COVID

U.S. 01/25/22, 13:03

The Food and Drugs Administration (FDA) decided to prohibit the use of monoclonal antibody treatments for COVID patients, arguing that they are not effective against the variant called Omicron. The decision was poorly received by Governor Ron DeSantis, one of the main promoters of these drugs. "Because data show these treatments ...

FDA panel endorses Merck’s first COVID-19 pill

U.S. 12/02/21, 04:09

On Tuesday, Nov. 30, the Food and Drug Administration (FDA) announced that a panel closely endorses Merck's first tightly monitored COVID-19 pill. The FDA voted 13-10 that the advantages of an antiviral medicine called "molnupiravir" exceed the hazards of using it during pregnancy, such as the possibility of birth abnormalities.This announcement ...

CDC backs vaccine booster for high risk workers, overrides panel

News 09/24/21, 15:24

The U.S. Centers for Disease Control and Prevention (CDC) on Friday, Sept. 24, said that it supports COVID-19 booster shots for people with high-risk jobs in addition to elders and adults with underlying conditions. “This updated interim guidance from CDC allows for millions of Americans who are at highest risk for ...

Pfizer booster shot: FDA panel votes no for general public

U.S. 09/18/21, 02:08

The U.S. Food and Drug Administration (FDA) has declined the plan to administer Pfizer booster shots to all eligible Americans. The decision was made after the vaccine advisory committee on Friday, Sept. 17, voted 16-2 against a proposal saying the Pfizer-made booster shot should be rolled out for those age16 and ...

Former FDA official: Biden administration should not dictate vaccine mandate

News 09/14/21, 01:36

Former Food and Drug Administration Commissioner Scott Gottlieb said the Biden administration should not dictate the COVID-19 vaccine mandate for businesses. In an interview on Face the Nation on Sunday, Sept. 12, Gottlieb suggested the vaccine mandate announced by President Biden last week is not necessary. “I don’t think we have to ...

FDA rejects Humanigen’s COVID-19 drug for emergency use, asks for more data

U.S. 09/10/21, 15:23

Humanigen, a clinical-stage biopharmaceutical company, announced on Thursday, Sept. 9, that the U.S. Food and Drug Administration (FDA) had rejected its request for emergency use authorization of its COVID-19 drug named Lenzilumab to treat newly hospitalized patients.  The California-based company, focusing on preventing and treating an immune hyper-response called “cytokine storm,” ...

Two senior vaccine regulators from FDA to resign in shock move

U.S. 09/01/21, 02:03

Two leading officials in charge of reviewing COVID-19 vaccine applications at the U.S. Food and Drug Administration (FDA) will step down this fall when the Biden administration prepares to offer vaccine booster shots to the public in September. Marion Gruber—director of the FDA’s Office of Vaccines Research & Review, and Phil ...

Surgeon General says even J&J vaccine may need booster shot

News 08/23/21, 02:42

Surgeon General Dr. Vivek Murthy, on Sunday, Aug. 22, said those who took the one-shot Johnson and Johnson (J&J) vaccines might eventually need another dose for more robust protection against coronavirus infection. “We believe that J&J recipients will likely need a booster, but we are waiting on some data from the ...

More salmonella illnesses have prompted a nationwide shrimp recall

News 08/17/21, 16:11

According to federal authorities, a salmonella outbreak has sickened nine people in four states, with three of them hospitalized. More than two dozen shrimp products sold nationwide are now being recalled.The FDA expanded an ongoing recall of frozen shrimp products from Avanti Frozen Foods over the weekend. Affected products include ...

Researchers want FDA to remove more sunscreens over cancer-causing chemical

News 08/12/21, 00:37

Multiple experts warn the Food and Drug Administration (FDA) of potentially cancer-causing compounds in some sunscreens, calling for them to be removed from the market. In a letter to the agency, the group of researchers said they had found an active ingredient called octocrylene in some sunscreens, which they said can ...

FDA authorizes COVID-19 antibody treatment for post-exposure prevention

U.S. 08/04/21, 16:15

A COVID-19 antibody treatment has now been approved by the Food and Drug Administration (FDA). Accordingly, the agency authorized the treatment for those who are unvaccinated or are immunocompromised, including those with autoimmune diseases, HIV patients, cancer patients, and organ transplant recipients, who have been or are at risk of being ...

Pfizer recalls anti-smoking drug Chantix for potential risk of cancer

News 07/22/21, 00:08

Pfizer, the influential pharmaceutical corporation, is recalling 12 batches of Chantix, a popular anti-smoking medication, after detecting excessive levels of a chemical linked to cancer. The Food and Drug Administration (FDA) on July 19 released a statement to inform that Pfizer has widened the voluntary recall of Chantix, or varenicline, to ...

Pfizer discusses booster COVID-19 shots with federal health officer

News 07/13/21, 02:12

Pharmaceutical giant Pfizer scheduled a meeting with the U.S. health official on Monday, July 12 seeking for an approval for the third dose of COVID-19 vaccine as cases rise across the country. Pfizer previously asserted that a booster shot of the COVID-19 vaccine is needed within 12 months. They learned from ...

FDA approves first Alzheimer treatment amid controversy

U.S. 06/08/21, 15:37

On Monday, June 7, the Food and Drug Administration approved a drug to treat Alzheimer's developed by Biogen Inc., despite skeptics disapproval since its clinical trial results were uninviting. This approval marks the first-ever therapy for Alzheimer's authorized by the FDA since 2003. There has not been any other drugs ...

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