FDA
FDA temporarily bans the use of monoclonal antibodies to treat COVID
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 ...
The FDA was forced to rush the distribution of the COVID-19 vaccine’s approval data
"The FDA should demand adequate, controlled studies with long term follow up, and make data publicly available, before granting full approval to COVID-19 vaccines", says Peter Doshi, an associate professor of pharmaceutical health services research in the School of Pharmacy and associate editor at the BMJ. Reuters reported last month ...
FDA panel endorses Merck’s first COVID-19 pill
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
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 ...
FDA amends emergency use authorization, allows Pfizer vaccine boosters for elderly and high-risk individuals
The U.S. Food and Drug Administration announced on Wednesday, Sept. 22, that it had amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine boosters, allowing them to be used for specific parts of the population. In its announcement, the FDA said that it now authorizes the use of a single ...
Pfizer booster shot: FDA panel votes no for general public
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
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
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
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
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
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
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 ...
Mandatory vaccination in Congress: Republicans and Democrats at odds over the dilemma
As the so-called ‘vaccine passport' begins to sound with more force in different environments with adherents and opponents to the measure, Republican and Democratic representatives also face the dilemma due to the completely different positions they hold, and that respond to their political ideology. On the premise of a new wave ...
FDA authorizes COVID-19 antibody treatment for post-exposure prevention
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
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 ...
US health officials claim booster shot unnecessary after meeting with Pfizer
There is no need for a third dose of the Chinese Communist Party (CCP) Virus vaccine, the Biden administration has said. The U.S. Department of Health and Human Services is not convinced that Pfizer's data provides enough evidence to prove CCP Virus booster shots are necessary to protect Americans from the ...
Pfizer discusses booster COVID-19 shots with federal health officer
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 ...
CDC: Heart inflammation among young adults who got the CCP Virus vaccine was unexpected
Last week, the Centers for Disease Control and Prevention (CDC) released a report that disclosed more information on the other concerning side effects seen in mRNA vaccines for CCP Virus, or coronavirus. Besides the dangerous blood clots, heart inflammation has come under notice. The heart-related symptoms were said to appear more ...
FDA approves first Alzheimer treatment amid controversy
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 ...
COVID-19 vaccine developers seeking FDA approval for their products: Why that should be a concern
Pfizer and BioNTech now want their experimental COVID-19 vaccines to be approved by federal officials. But is it the right time for that? As a significant portion of Americans is now fully vaccinated, Pfizer-BioNTech, on May 7, filed an application to the Food and Drug Administration (FDA) for approval of a ...
End of content
No more pages to load
