A new Alzheimer’s treatment would cost patients an estimated $26,500 per year, said the drug developer. The Food and Drug Administration (FDA) announced on Jan. 6 that it would grant accelerated approval to Biogen and Eisai, after the drug appeared to partially slow the development of mild cases of Alzheimer’s disease in clinical trials. The same day, Eisai submitted…
Internal Emails Show Pfizer Board Member (former FDA Director) Censoring Natural Immunity on Twitter | Facts Matter
With a brand new batch of internal Twitter documents having just been released, we have a clearer glimpse into the type of hidden censorship that people have been subject to for the past three years when trying to post things about either COVID or the vaccine. According to a new batch of internal emails just…
FDA Panel to Review Emergent’s Over-the-Counter Opioid Overdose Drug
The U.S. health regulator said on Tuesday its advisory panel will meet on Feb. 15 to review Emergent Biosolutions Inc.’s over-the-counter (OTC) nasal spray to treat suspected opioid overdoses. Emergent is seeking the Food and Drug Administration’s (FDA) approval for the prescription-free sale of Narcan, its nasal spray form of the drug naloxone. Narcan is…
Is the FDA Working for Drug Makers or Drug Users?
The U.S. Federal Food and Drug Administration’s (FDA) origins as a federal consumer protection agency began with the passage of the 1906 Pure Food and Drugs Act. But its founding was not sufficient to prevent poor-quality food and medication from flooding the market. By 1938, in response to public outrage, Congress passed the Food, Drug, and…
Lecanemab May Reverse Alzheimer’s Disease But 3 Deaths Raise Questions
The U.S. Food and Drug Administration (FDA) granted Leqembi accelerated approval on Jan. 6, 2023. It is the seventh drug the FDA has approved for the treatment of Alzheimer’s disease. The generic name of the drug is Lecanemab. It has been developed by the Japanese company Eisai in partnership with the U.S. company Biogen. These are…
FDA Greenlights Diabetes Drug to Treat Teens With Obesity
The U.S. Food and Drug Administration (FDA) has approved semaglutide, a type 2 diabetes drug that recently gained social media fame, for weight loss for teenagers with obesity. The drug, approved under the brand name Wegovy, is so far the only prescription anti-obesity medicine for children as young as 12 with once-a-week injection, according to…
FDA Deviated From Normal Process in Pfizer Vaccine Approval, Documents Show
U.S. drug regulators acknowledged deviating from the normal vaccine approval process when dealing with Pfizer’s COVID-19 shot, according to newly disclosed documents. Weeks after Pfizer and its partner BioNTech announced they started a rolling submission of documents for approval of their COVID-19 vaccine, a U.S. Food and Drug Administration official penned a memorandum authorizing the…
FDA Grants Accelerated Approval for Alzheimer’s Drug Lecanemab
The U.S. Food and Drug Administration (FDA) on Friday granted accelerated approval for the experimental dementia drug lecanemab. Lecanemab, which will be marketed as Leqembi, is the second of a new class of Alzheimer’s disease drugs that target the illness’s core pathophysiology, according to the FDA, which said the drug is a significant step forward…
FDA Rejects Petitions Related to Abortion Pill Mifepristone
The U.S. Food and Drug Administration (FDA) recently denied two petitions—one from pro-life group Students for Life, and one from the American College of Obstetricians and Gynecologists (ACOG)—regarding an abortion pill, marking the latest move in efforts to determine regulation over chemical abortion. Chemical abortion, also referred to by other terms such as “abortion by medication,”…
Capitol Report: Biden to Make First Trip to Southern Border; McCarthy Bid for Speaker Enters Day 3, New Nominations Emerging
President Joe Biden is finally set to visit the border. He gave his answer on what took so long and announced a new immigration program Thursday. Thursday marks Day 3 of multiple rounds of votes, and no speaker is running the House of Representatives yet. Another name is in the race, as well as a surprising stray vote…
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