Food and Drug Administration
Federal agency in the United States
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- Regulatory Approval (7)
- Public Health (6)
- Regulatory Compliance (4)
- Pharmaceuticals (4)
- Drug Development (4)
- Biotech (3)
- Healthcare (3)
- Food Safety (3)
- Finance (2)
- Healthcare Regulation (2)
- Medical Devices (2)
- Rare Disease Treatment (2)
🏷️ Keywords
FDA (49) · FDA approval (12) · drug approval (5) · Trump administration (5) · treatment (5) · biotech (4) · public health (4) · clinical trial (3) · drug development (3) · vaccine chief (3) · departure (3) · Vinay Prasad (3) · Moderna (3) · stock price target (2) · biotechnology (2) · investment (2) · stock rating (2) · cancer drug (2) · misleading claims (2) · warning letter (2)
📖 Key Information
📰 Related News (61)
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🇺🇸 Restylane Contour Gets FDA Approval for Temple Hollowing
A new indication brings the upper face into focus....
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🇺🇸 Doctors worry about FDA scrutiny of RSV shots to protect babies
The antibody shots are about 80% effective at preventing babies from ending up in intensive care because of RSV. The drugmakers behind them maintain t...
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🇺🇸 FDA says billionaire's claims about cancer drug Anktiva are misleading
Federal health officials posted a warning about misleading statements by biotech billionaire Dr. Patrick Soon-Shiong about his company's bladder cance...
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🇺🇸 FDA flags misleading claims for cancer drug by biotech billionaire Patrick Soon-ShiongFederal health officials have issued a warning about controversial statements made by biotech billionaire Dr. Patrick Soon-Shiong about one of his com...
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🇺🇸 FDA Approves Wegovy HD, a Higher-Dose Option for GLP-1 Patients
A closer look at the new dose and who it’s intended for....
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🇺🇸 Pfizer to seek FDA approval for Lyme disease vaccine candidate despite trial miss
Lyme disease is an illness caused by bacteria most commonly spread to humans from ticks. It can cause arthritis, muscle weakness and pain....
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🇺🇸 FDARxBench: Benchmarking Regulatory and Clinical Reasoning on FDA Generic Drug Assessment
arXiv:2603.19539v1 Announce Type: cross Abstract: We introduce an expert curated, real-world benchmark for evaluating document-grounded question-answ...
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🇺🇸 FDA backs off stricter tanning bed rules with RFK Jr.'s support
Health officials with the Trump administration have backed away from an effort to more heavily regulate indoor tanning — despite protests from medical...
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🇺🇸 FDA approves higher dose of WegovyThe Food and Drug Administration (FDA) on Thursday approved a higher dose of the Wegovy weight loss drug. The manufacturer, Novo Nordisk, increased th...
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🇺🇸 FDA pulls proposed rule banning teens from using tanning bedsThe Food and Drug Administration on Tuesday withdrew a proposed rule that would have barred all Americans under age 18 from using tanning beds....
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🇺🇸 F.D.A. Investigates 7 E. Coli Illnesses as Raw Dairy Farm Denies Any LinkThe outbreak has sickened people in California, Texas and Florida. The agency said Cheddar cheese products from Raw Farm are “the likely source,” but ...
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🇺🇸 Dietary supplement recalled for containing active ingredient in ViagraThe product, Primal Herbs Volume, is packaged in 8 1/2-ounce containers with green labels and sold online....
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🇺🇸 Viagra drug found in 'wellness' supplement prompts nationwide recallA New Mexico-based company is recalling one of its supplements after a lab found it to contain the erectile dysfunction drug sildenafil, according to ...
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🇺🇸 Hawley introduces bill to remove FDA approval for MifepristoneSen. Josh Hawley (R-Mo.) on Wednesday unveiled his legislation to remove Food and Drug Administration (FDA) approval for the use of Mifepristone to en...
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🇺🇸 FDA sends warning letter to Novo Nordisk over failure to report deaths, adverse side effects of GLP-1sThe U.S. Food and Drug Administration (FDA) has issued a warning to Novo Nordisk over its alleged failure to report adverse side effects, including de...
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🇺🇸 FDA warns Novo Nordisk over unreported potential Ozempic side effects
The FDA issued a warning letter to Novo Nordisk, the Danish drugmaker behind the diabetes and weight-loss medications Ozempic and Wegovy, over unrepor...
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🇺🇸 FDA finds little evidence that generic drug leucovorin could help many people with autismThe Food and Drug Administration on Tuesday approved a generic medication for a rare brain disorder, while walking back suggestions by President Trump...
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🇺🇸 FDA finds little evidence that a generic drug can help people with autismThe FDA is approving a generic drug for a very rare genetic disorder, but not for autism...
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🇺🇸 Why the 'mad scramble' to fill hormone therapy prescriptions for menopause
With the removal of FDA warning labels, hormone therapy to treat symptoms of menopause has grown in popularity. Now some patients are reporting delays...
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🇺🇸 Public trust in NIH, FDA and CDC continues to fallPresented by the Coalition to Strengthen America's Healthcare {beacon} Health Care Health Care The Big Story Public trust in NIH, FDA and CDC conti...
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🇬🇧 US agency did not perform safety checks of more than 100 food ingredients, analysis finds<p>Review of FDA records by the Environmental Working Group reveals firms are exploiting rule to send new chemicals in food system</p><p>More than 100...
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🇺🇸 Trump administration's embattled FDA vaccine chief is leaving — again
In July, Prasad was briefly forced from his job, but was reinstated less than two weeks later....
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🇺🇸 Top FDA regulator to leave the agencyFood and Drug Administration (FDA) Commissioner Marty Makary on Friday announced that the agency's top regulator Vinay Prasad will depart next month. ...
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🇺🇸 Trump administration's embattled FDA vaccine chief is leaving for the second time
The FDA's controversial vaccine chief, Dr. Vinay Prasad, is leaving the agency. It's the second time he has abruptly departed following deci...
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🇺🇸 Divisive F.D.A. Vaccine Regulator Is ResigningDr. Vinay Prasad drew criticism for overriding career scientists and rejecting drugs by companies seeking agency approval....
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🇬🇧 Trump administration’s embattled FDA vaccine chief ousted for the second time<p>Vinay Prasad to leave in April after decisions involving vaccine reviews and specialty drugs for rare diseases</p><p>The Food and Drug Administrati...
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🇺🇸 FDA vaccine head will step down in April after string of controversial decisions
Vinay Prasad is leaving his post as director of the Center for Biologics Evaluation and Research....
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🇺🇸 FDA reversals leave investors worrying about the fates of other experimental drugs
Investors are scrutinizing the prospects for some drugs in the pipeline following a string of recent rejections from the U.S. Food and Drug Administra...
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🇺🇸 FDA watchers warn of 'chaos' inside agency, as regulatory delays, staff hemorrhaging risk America's health
Scientific, political pressures colliding at FDA, delaying rare disease treatment for patients who have few or no options, experts said at CNBC Cures ...
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🇺🇸 The FDA creates a quicker path for gene therapies
The Food and Drug Administration aims to evaluate treatments for rare diseases based on plausible evidence that they would work — without requiring a ...
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🇺🇸 FDA proposes new treatment approval pathway for ultra-rare diseasesThe Food and Drug Administration (FDA) on Monday announced a new proposal for flexible drug approval pathway treatments addressing ultra-rare diseases...
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🇺🇸 Gilead to acquire cancer therapy developer Arcellx for up to $7.8 billion
Gilead Sciences said on Monday it will buy cancer therapy partner Arcellx for an implied equity value of $7.8 billion....
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🇺🇸 Gerber recalls some arrowroot biscuits over potential plastic, paper pieces
The recall affects several batches of the 5.5-ounce Gerber Arrowroot Biscuits, the FDA said....
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🇺🇸 F.D.A. Reverses Decision and Agrees to Review Moderna’s Flu VaccineModerna said it had held further discussions with regulators and announced that the agency would accept the company’s application for approval of its ...
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🇺🇸 FDA will drop two-study requirement for new drug approvals, aiming to speed accessThe Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies to win approval for new drugs, the latest chang...
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🇺🇸 News Wrap: Bhattacharya to serve as acting head of CDCIn our news wrap Wednesday, the National Institutes of Health Director Dr. Jay Bhattacharya will serve as acting head of the CDC, the FDA reversed its...
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🇺🇸 U.S. Health Officials Defend Rejection of Moderna’s Flu VaccineThe F.D.A.’s refusal to examine the company’s mRNA shot drew widespread criticism from doctors and was divisive within the agency....
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🇺🇸 FDA investigating Salmonella outbreak connected to moringa powderRosabella-brand moringa capsules could be linked to Salmonella cases in seven U.S. states, health officials said....
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Semaglutide · 3 shared articles -
Vinay Prasad · 3 shared articles -
Moderna · 3 shared articles -
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Savara · 2 shared articles
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Sildenafil · 2 shared articles -
Centers for Disease Control and Prevention · 2 shared articles -
Novo Nordisk · 2 shared articles -
Weight loss · 1 shared articles -
Telehealth · 1 shared articles