Por: The Hill Health December 30, 2022
The Food and Drug Administration (FDA) is fast-tracking the review for a new opioid overdose reversal drug that would be available over the counter. The nonprofit pharmaceutical company Harm Reduction Therapeutics on Monday said in a the FDA had granted it priority review for a new drug application for RiVive, a naloxone nasal spray for emergency overdose treatment. without a prescription, but sold behind the counter. Harm Reduction... + full article
Politico USA Health December 30, 2022
The FDA’s collaboration with Biogen, the maker of a controversial Alzheimer’s drug, before it granted the product accelerated approval was “atypical” and ran afoul of the agency’s protocol for documenting interactions with drug companies, according to a joint House... + más
Alzheimer's drug approval by FDA 'rife with irregularities,' probe finds | Los Angeles Times
Probe: Alzheimer's drug approval 'rife with irregularities' | ABC News
Los Angeles Times USA Science December 30, 2022
The Food and Drug Administration’s contentious approval of a questionable Alzheimer’s drug took another hit Thursday as congressional investigators called the process “rife with irregularities.” The 18-month investigation by two House committees detailed “atypical... + más
Probe: Alzheimer's drug approval 'rife with irregularities' | WPLG Local 10
Associated Press USA Politics December 19, 2022
WASHINGTON (AP) — The lack of clear direction and priorities at the U.S. Food and Drug Administration’s tobacco division has hampered its ability to regulate electronic cigarettes and other products, according to an expert panel assembled to examine problems at the agency.A... + más
Panel warns FDA’s beleaguered tobacco unit lacks direction | ABC News
Panel warns FDA’s beleaguered tobacco unit lacks direction | WPLG Local 10
The Hill USA Health December 08, 2022
Leave it to Ticketmaster to unite Republicans and Democrats: Bipartisan members of the House Energy and Commerce Committee want a briefing about the company’s Taylor Swift debacle. Today in health, lawmakers are on the verge of getting rid of the Pentagon’s COVID-19... + más
ALS drug wins FDA approval despite questionable data | ABC News
ALS drug wins FDA approval despite questionable data | WPLG Local 10
NBC News USA Nation November 16, 2022
The Food and Drug Administration is pushing for drugmakers to apply for over-the-counter approval for naloxone, the opioid overdose antidote. In a notice published online Tuesday, the agency said that it “strongly encourages” naloxone makers to contact the FDA “as early as... + más
Why Overdose Deaths Have Increased | Time
US overdose deaths may be peaking, but experts are wary | WPLG Local 10
ABC News USA Health September 30, 2022
WASHINGTON -- A much-debated drug for Lou Gehrig’s disease won U.S. approval Thursday, a long-sought victory for patients that is likely to renew questions about the scientific rigor behind government reviews of experimental medicines.Amylyx Pharmaceuticals said the Food and... + más
Highly debated Amylyx Pharmaceuticals ALS drug wins FDA approval | New York Post
New York Post USA Life September 30, 2022
A much-debated drug for Lou Gehrig’s disease won US approval on Thursday from the Food and Drug Administration. The nod represents a long-desired victory for patients, though it is likely to renew questions about the scientific rigor behind government reviews of... + más
ALS drug gets FDA approval despite uncertainty about effectiveness | ABC7
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