An international group of vaccine experts, including officials from the Food and Drug Administration (FDA) and World Health Organization (WHO), said that there is no evidence to suggest that the general population needs COVID-19 vaccine booster shots. The authors warned that if booster shots are introduced too soon, they may cause more side effects in…
FDA Leaders, Other Scientists Say Most People Don’t Need Vaccine Boosters
Live Q&A: Biden to Announce Global COVID Measures; Vaccines May Be Authorized for Children
President Joe Biden is expected to announce global measures for COVID-19 this week, according to the surgeon general. And in other news, the FDA may soon approve the Pfizer vaccine for children as young as 5, according to the agency’s former chief. In this live Q&A with Crossroads host Joshua Philipp, we’ll discuss these stories…
FDA Delays Decision on Juul E-Cigarettes
The Food and Drug Administration (FDA) said on Thursday it needs more time to decide whether e-cigarette maker Juul Labs Inc. and other major manufacturers can sell their products in the United States. The agency had been expected to make a decision by Thursday, a year after Juul and other e-cigarette brands, including British American…
FDA Denies Emergency Use Approval to New COVID-19 Drug
The U.S. Food and Drug Administration (FDA) declined emergency use approval for a lenzilumab monoclonal antibody drug to treat COVID-19, according to Humanigen. Humanigen, the developer of the drug, sought the FDA’s emergency use authorization for the medication to treat newly hospitalized COVID-19 patients. The firm filed its petition with the drug regulator in May 2021. “In its…
FDA Denies Emergency Use Authorization for New COVID-19 Drug
The U.S. Food and Drug Administration (FDA) declined emergency use authorization for a lenzilumab monoclonal antibody drug to treat COVID-19, according to Humanigen. Humanigen, the developer of the drug, sought the FDA’s emergency use authorization for the medication to treat newly hospitalized COVID-19 patients. The firm filed its petition with the drug regulator in May 2021. “In its…
Two High-Level FDA Vaccine Officials Stepping Down Soon: Spokeswoman
Two senior Food and Drug Administration (FDA) vaccine regulators are planning to leave the agency in the coming weeks, said the FDA on Tuesday. The regulator is “confident in the expertise and ability of our staff to continue our critical public health work, including evaluating COVID-19 vaccines,” FDA spokeswoman Stephanie Caccomo said in a statement…
Will Snuffing out Fine Latin Cigars Strike the Match of Illegal Immigration?
Cigar diplomacy is back—and once again it is clouding the landscape for an American president. As the Cold War raged in 1962, a trade embargo against Fidel Castro’s communist government in Cuba was an easy political call for John F. Kennedy. The president had a personal conflict-of-interest, however: JFK loved a good smoke. So he…
Pfizer Board Member: ‘Natural Immunity’ Against COVID-19 Needs to Be Included in Policy Discussions
Former Food and Drug Administration Commissioner Scott Gottlieb, who’s a Pfizer board member, noted that “natural immunity” gained from a prior COVID-19 infection needs to be included in discussions about virus-related policies and mandates. “The balance of the evidence demonstrates that natural immunity confers a durable protection,” Gottlieb said during an Aug. 30 interview, referring…
Pfizer Board Member: ‘Natural Immunity’ Against COVID Needs to Be Included in Policy Discussions
Former Food and Drug Administration Commissioner Scott Gottlieb, who is a Pfizer board member, noted that “natural immunity” gained from a prior COVID-19 infection needs to be included in discussions about policies and mandates. “The balance of the evidence demonstrates that natural immunity confers a durable protection,” Gottlieb said during a Monday morning TV interview,…
FDA Bans Sale of 55,000 Flavored E-Cigarette Products
The U.S. Food and Drug Administration (FDA) banned sales of about 55,000 flavored e-cigarette products on Thursday because of the health threat they pose to American youth. “The applications for about 55,000 flavored ENDS products from three applicants lacked sufficient evidence that [e-cigarettes] have a benefit to adult smokers sufficient to overcome the public health threat posed…
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