Topic
FDA
60 stories related to this topic, newest first.
nypost.comscience4 days ago
FDA Finds 19 Metals in Tampons, Says Levels Pose No Health Risk
The FDA analyzed 11 tampon products from six brands and found 19 metals present. Researchers concluded that exposure levels during normal use remain below safety thresholds.
forbes.comscience5 days ago
Finalists for FDA Commissioner Sent to White House for Review
@statnews reported that three candidates are under final consideration to lead the agency. The shortlist arrives as the FDA operates under acting leadership amid ongoing regulatory responsibilities.
video.foxbusiness.comscience12 days ago
FDA Upgrades Potato Chip Recall to Class 1 Over Salmonella Risk
The U.S. Food and Drug Administration raised a voluntary recall of multiple potato chip brands to its highest severity level. The action covers an estimated 650,000 bags produced by Utz.
news.sky.comworld13 days ago
FDA Allows ZYN Nicotine Pouches to Claim Lower Risks Than Cigarettes but Bars Fruity Flavors
The Food and Drug Administration on Tuesday authorized Swedish Match USA to market 20 ZYN products with reduced-risk claims for mouth cancer, heart disease and other conditions. The decision covers Cool Mint, Citrus, Coffee and Cinnamon flavors in 3-milligram and 6-milligram stre…
biopharmadive.comscience14 days ago
Beeline Medicines Raises $126.3 Million in Series A Extension
Bain Capital Life Sciences-backed startup Beeline Medicines secured additional funding. Separately, the acting director of the FDA office reviewing cell and gene therapies announced his departure. Both developments were reported June 30, 2026.
cnbc.comworld14 days ago
FDA Allows Philip Morris to Market Zyn Nicotine Pouches With Reduced-Risk Claims but Warns No Tobacco Product Is Safe
The Food and Drug Administration on Tuesday cleared Philip Morris to market 20 Zyn nicotine pouch products as less harmful than cigarettes. The order permits specific claims that switching from cigarettes lowers risks for several major diseases. It expands a January 2025 authoriz…
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biopharmadive.comscience14 days ago
Nearly 1 Million Bottles of Heart Failure Drug Recalled
A nationwide recall covers 934,577 bottles of Corlanor after the manufacturer reported possible foreign substance contamination. The FDA classified the action as Class II, indicating temporary or reversible health risks.
propublica.orgworld14 days ago
FDA Releases List of Participants for July Peptide Safety Review Meeting
The Food and Drug Administration on Monday named the experts who will assess seven peptide injections next month. Several panel members operate clinics or pharmacies that sell the compounds under review.
ww2.kqed.orgscience16 days ago
Democratic lawmakers seek details on patient given early access to Eli Lilly obesity drug
Two Democratic members of Congress are asking the Trump administration for more information about a 79-year-old patient approved in April for compassionate-use access to an experimental obesity treatment. The lawmakers want to know whether the patient is a high-profile individual…
science18 days ago
Senate Health Committee Chair Introduces Bill to Restrict 340B Drug Discount Program
The legislation would let drugmakers issue retroactive rebates and impose new rules on hospitals and contract pharmacies. Separately, the Trump administration is considering Jeff Vacirca to lead the FDA.
benzinga.comscience18 days agoUpdated
Senator Introduces Bill to Restrict 340B Drug Discount Program
Sen. Bill Cassidy introduced legislation on June 26, 2026, that would overhaul the federal 340B program by allowing retroactive rebates instead of upfront discounts. The measure would also require hospitals to pass savings to patients and impose limits on contract pharmacies.
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benzinga.comscience19 days agoUpdated
Democratic lawmakers seek details on special access to experimental obesity drug
Two members of Congress are asking the White House for information on a 79-year-old patient granted early access to an experimental obesity treatment. The request follows reporting that the drug was provided through the FDA's compassionate use program.
benzinga.comscience21 days ago
Eli Lilly Provided Experimental Obesity Drug to One Patient via FDA Compassionate-Use Program
STAT reported that Eli Lilly supplied its experimental obesity drug retatrutide to a single 79-year-old man via the FDA’s compassionate-use pathway in April. The access drew attention from top health officials. Three sources requested anonymity citing fear of reprisals.
benzinga.comscience21 days ago
Eli Lilly Supplied Experimental Obesity Drug to One Patient via FDA Compassionate-Use Program
Stat reported that Eli Lilly supplied its experimental drug retatrutide to a single patient through the FDA’s compassionate-use pathway in April. The request involved a 79-year-old man and drew attention from senior health officials. Retatrutide has produced substantial weight lo…
fda.govscience21 days ago
FDA to Reconsider Gene Therapy for Rare Childhood Brain Disorder
The U.S. Food and Drug Administration will review an experimental gene therapy rejected four months earlier. The United States also opened a trade investigation into German plans to cut pharmaceutical spending by $23 billion.
Statscience22 days ago
FDA Will Reconsider Gene Therapy for Hunter Syndrome After Earlier Rejection
The Food and Drug Administration will review again an experimental gene therapy for mucopolysaccharidosis type II that it rejected four months ago. The move follows recent leadership changes at the agency.
montrealgazette.comworld22 days ago
FDA Advisory Committee Recommends Approval of Moderna's mRNA Flu Vaccine
An FDA vaccine advisory committee voted unanimously to recommend Moderna's mRNA-based flu vaccine for adults 50 and older. The vaccine showed 27 percent greater effectiveness than standard shots in late-stage trials.
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rte.iescience22 days ago
FDA Advisory Panel Backs Moderna mRNA Flu Vaccine for Older Adults but Final Approval Remains Pending
VRBPAC voted unanimously on June 18 that benefits outweigh risks for adults ages 50-64 and 65+. The final FDA decision on licensure remains pending.
abcnews.go.comscience25 days ago
FDA Panel Backs Moderna mRNA Flu Vaccine for Adults 50 and Older, but Final Licensing Decision Remains Pending
The Vaccines and Related Biological Products Advisory Committee voted unanimously on June 18, 2026, that benefits of the vaccine outweigh risks for adults ages 50–64 and 65 and older. The final FDA licensing decision has not yet been made.
abcnews.go.comscience25 days agoUpdated
FDA Panel Endorses Moderna mRNA Flu Vaccine for Ages 50 and Up but Requires Further Trial for Ages 65 and Older
An advisory committee voted unanimously Thursday to support licensure of the shot for adults aged 50–64 via the traditional pathway and for adults 65 and older via the accelerated pathway. The FDA is expected to decide by August 5.
sciencenews.orgpolitics28 days ago
FDA Expands Permitted Sunscreen Ingredients for First Time in Over 20 Years
The Food and Drug Administration will allow additional sunscreen ingredients this summer. The change marks the first expansion of approved options in more than two decades.
Usa Todayscience29 days ago
Nasal spray sold on Amazon recalled over possible mold contamination
A voluntary recall covers one lot of Beekeeper’s Naturals Saline Nasal Spray sold on Amazon after tests showed yeast levels above limits and possible Aspergillus mold. The company received four adverse-reaction reports linked to the product.
theweek.comtechnology30 days agoUpdated
FDA Approves Xolair for Alpha-Gal Syndrome in 2024
The injectable drug reduces severe reactions in people with the tick-triggered meat allergy. Roughly 450,000 Americans are estimated to have the condition.
nypost.comworld31 days ago
FDA Clears Over-the-Counter Nitenpyram for Pets After New World Screwworm Found in Texas and New Mexico
The U.S. Food and Drug Administration cleared emergency use of generic Nitenpyram Tablets for dogs, puppies, cats and kittens after infections appeared in Texas and New Mexico livestock and one dog.
oneindia.comworld32 days ago
FDA Grants Emergency Use of Nitenpyram for Screwworm in Pets
The U.S. Food and Drug Administration authorized nitenpyram tablets for dogs and cats weighing at least two pounds and four weeks old. The drug is the first generic approved against New World screwworm larvae.
The Guardianscience32 days ago
Clinics Offer Umbilical Cord Stem Cell Injections to Autistic Children
U.S. clinics in Florida, Texas and other states are providing unapproved umbilical cord stem cell infusions to autistic children as young as 18 months. The treatments cost up to $20,000 per session and lack FDA approval. Health and Human Services Secretary Robert F. Kennedy Jr. h…
Fortunefinance32 days ago
FDA Authorizes First Fruit-Flavored Vapes After Study Shows Higher Cigarette-Switching Rates
The agency issued its first approval of fruit-flavored e-cigarettes after a three-month study showed no statistically significant advantage over tobacco flavors. A six-page memo released this week left out key details such as the number of participants.
Abc Newsscience33 days ago
FDA Memo Shows Fruit E-Cigarettes Did Not Outperform Tobacco Flavors in Quitting
A six-page FDA memo released this week found no statistically significant difference in adult quitting rates between the newly authorized fruit-flavored vapes and tobacco-flavored versions. The document provides additional details on the agency's May authorization of the first fr…
benzinga.comscience34 days ago
FDA Issues Complete Response Letter to AbbVie on TrenibotE Application Citing Manufacturing Issues
AbbVie received a Complete Response Letter from the U.S. Food and Drug Administration on June 10, 2026, regarding its Biologics License Application for trenibotulinumtoxinE.
finance34 days ago
FDA Approves Bemotrizinol for Use in U.S. Sunscreens
The FDA approved bemotrizinol, a UV filter used in Europe and Asia for more than 20 years. The approval marks the first new sunscreen ingredient cleared in the United States since 1999. New products containing the ingredient are not expected for over a year.
benzinga.comscience35 days ago
GSK Acquires Rights to Three Experimental Lung Cancer Drug Candidates, Two Under FDA Review
The deal will transfer ownership of three experimental treatments, two of which are already under FDA review for approval this year.
nbcnews.comscience39 days ago
FDA Faces Calls to Pause Makary Drug Voucher Program, Reintroduce via Formal Rulemaking
Patient advocates, former agency officials, and industry players want the FDA to halt the drug voucher program and restart it through formal rulemaking.
benzinga.comscience42 days ago
FDA Lets Vera Analyze Atacicept Phase 3 Data a Year Early as Accelerated Approval Decision Nears
Vera Therapeutics reached an agreement with the FDA to speed up analysis of its confirmatory Phase 3 study for atacicept in IgA nephropathy. A decision on accelerated approval is expected by July 7.
Statscience44 days ago
BioNTech and Pfizer Present Bispecific Antibody Data at Oncology Meeting
BioNTech and Pfizer presented data on bispecific antibodies at the American Society of Clinical Oncology annual meeting. The companies highlighted results from studies involving new immunotherapies. Coverage also noted comments from an FDA official on agency operations.
Statscience45 days ago
Rick Pazdur: FDA Turmoil Creates Opportunity to Rebuild Agency with Industry and Academic Talent
Former top oncology regulator Rick Pazdur told a STAT audience in Chicago that recent political appointees caused substantial destruction at the FDA and that new leadership should rebuild rather than restore the prior structure.
medpagetoday.comscience46 days ago
FDA Panel Recommends XFG Variant for Fall Covid Shots
Replimune will submit an application to the FDA for the third time. Pfizer and Innovent Biologics reached a collaboration agreement valued at up to $10.5 billion.
Newsweekworld46 days ago
Wawa Beverage Company Recalls Four Drinks Over Possible Undeclared Milk
Wawa Beverage Company issued a voluntary recall of four beverages on April 3 after a temporary equipment issue may have introduced undeclared milk. The FDA later classified the recall as Class I, the agency's highest risk level.
foxbusiness.comworld46 days ago
FDA Rejects Experimental Melanoma Drug Twice Over Study Design
The Food and Drug Administration turned down an experimental melanoma treatment on two separate occasions after raising questions about how the supporting clinical study was structured. The agency cited concerns with the trial's design as the basis for both rejections.
The Independentscience48 days ago
FDA Reports Recall of Coffee, Tea and Boba Mixes in 25 States
The U.S. Food and Drug Administration announced a recall of multiple drink and dessert mixes distributed by SKS Copack after the products were found to contain a dry milk powder recalled for possible salmonella contamination.
New York Postbusiness50 days ago
Raaw Energy Expands Recall of Frozen Dog Food Over Listeria
Raaw Energy is expanding a recall of frozen dog food products after federal testing found Listeria monocytogenes. The recall covers items made between July 2025 and March 2026 and sold in nine states.
Newsweekworld50 days ago
FDA Assigns Class I Risk Level to Honeyville Banana Smoothie Recall
The U.S. Food and Drug Administration classified a voluntary recall of 4,980 pounds of banana smoothie mix as Class I on May 22. The recall, initiated by Honeyville Inc. on May 21, covers product distributed in California and Utah.
foxnews.comscience51 days ago
Cancer Immunotherapy Pipeline Expands With Multiple New Drug Classes
More than 2,500 cancer immunotherapy programs are now active. Fifteen years after the first checkpoint inhibitor approval, several additional drug types have reached FDA approval or late-stage testing.
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Statscience55 days ago
FDA Leadership Changes Prompt Concerns Among Rare Disease Drug Developers
Drug industry executives and an academic expert discussed the effects of recent FDA personnel changes on rare disease drug development at a conference in San Francisco on May 20, 2026. They expressed uncertainty about clinical trial requirements and investor reactions.
fda.govscience55 days ago
FDA Encourages Shift From Animal Testing Models
The FDA is urging pharmaceutical companies to reduce reliance on animal testing. Betts Lacroix stated that current technology does not yet support complete replacement of animal models.
thehindu.comscience55 days ago
Former FDA Commissioner David Kessler Discusses Agency Challenges
David Kessler, who previously led the Food and Drug Administration, offered comments on the agency's current condition and possible next steps. The remarks were shared during a STAT Breakthrough event.
prnewswire.comscience56 days ago
Former FDA Commissioner Says Acting Head Can Stabilize Agency
Former FDA commissioner David Kessler said acting commissioner Kyle Diamantas has the background to bring stability to the agency during a period of leadership changes. Kessler spoke at the STAT Breakthrough Summit West in San Francisco on Tuesday.
forbes.comfinance57 days ago
FDA Leadership Changes After Commissioner Departure
Marty Makary has left the position of FDA commissioner. An acting replacement now leads the agency that oversees medicines, vaccines, food, and medical devices.
Statpolitics59 days ago
FDA Commissioner Marty Makary Resigns After One Year in Trump Administration
Marty Makary stepped down from the FDA on Tuesday, ending a tenure that began with a high-profile announcement on Covid-19 vaccine recommendations alongside Robert F. Kennedy Jr. and Jay Bhattacharya. His arrival coincided with mass dismissals of career officials by the Departmen…
Statscience59 days ago
Acting Director of FDA Drug Center Tracy Beth Høeg Leaves Agency
Tracy Beth Høeg, acting director of the Food and Drug Administration’s Center for Drug Evaluation and Research, is departing the agency. The departure comes days after Commissioner Marty Makary submitted his resignation. Michael Davis, the center’s current deputy director, will a…
thebalitimes.comworld60 days ago
FDA Rejects Replimune Melanoma Treatment RP1
The Food and Drug Administration declined to approve RP1, a genetically engineered treatment for melanoma developed by Replimune. One-third of participants in a 140-patient clinical trial saw their tumors shrink or disappear. The agency cited the lack of a control arm comparing t…
Statscience61 days ago
Regenxbio Gene Therapy for Duchenne Muscular Dystrophy Succeeds in Trial
Regenxbio announced on May 14, 2026 that its experimental treatment produced high levels of a miniaturized muscle protein, clearing the path for an FDA submission. The Rockville, Md.-based company aims to offer a safer and more effective option than Sarepta Therapeutics’ Elevidys…
thehindu.comscience62 days ago
Trump Administration Seeks Next FDA Commissioner to Rebuild Trust and Advance Reforms
The administration is moving quickly to find a successor after FDA Commissioner Marty Makary resigned on Tuesday. Officials want the next leader to rebuild trust with agency staff, emphasize food policy and continue drug-approval reforms. The search is expected to take several we…
upi.comscience61 days agoUpdated
FDA Approves Flavored Vapes; Commissioner Marty Makary Resigns
Marty Makary stepped down on May 12, 2026, after one year in the post, citing private opposition to the Trump administration's approval of blueberry and mango flavored vape pods manufactured by Glas Inc. HHS chief spokesperson Rich Danker resigned the next day over the same polic…
Nbc Newspolitics62 days agoUpdated
Trump Removes FDA Commissioner Marty Makary
President Donald Trump announced Tuesday that Dr. Marty Makary has left his position as FDA commissioner following weeks of reported tensions with the White House. Kyle Diamantas, the agency's former top food official, will serve as acting commissioner.
kr-asia.comscience63 days ago
Bristol Myers Squibb Partners With China’s Hengrui Pharma on More Than a Dozen Early-Stage Programs
Bristol Myers Squibb announced a partnership with Hengrui Pharma covering more than a dozen early-stage programs on May 12, 2026. Hims & Hers reported first-quarter sales of $608 million, below analyst estimates, and posted a net loss of $92 million. Other biotech developments in…
abcnews.go.compolitics63 days ago
Supreme Court Extends Administrative Stay on Mifepristone Restrictions Until Thursday
Justice Samuel A. Alito Jr. extended an administrative stay on May 11, 2026, pausing a U.S. Court of Appeals for the Fifth Circuit ruling against the Food and Drug Administration. Full access to mifepristone, including through telemedicine and the mail, will continue for at least…
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cnbc.comscience63 days ago
Supreme Court Faces Deadline on Mifepristone Mail-Order Case
The Supreme Court is expected to take further action by the end of May 12, 2026 in a case involving mail orders of mifepristone, the abortion medication. A federal appeals court had ruled to stop such mail orders. The outcome could affect FDA regulatory authority over drug dispen…
The Bbcscience63 days ago
Marty Makary Resigns as FDA Commissioner
President Donald Trump confirmed the departure of Marty Makary, who had served as FDA commissioner since March 2025. Kyle Diamantas, the agency's top food regulator, will step in as acting commissioner. Makary is the latest top health official to leave under Health and Human Serv…
Statscience64 days ago
FDA Updates Enforcement Priorities for E-Cigarettes and Nicotine Pouches Pending Application Review
The agency will not prioritize action against manufacturers whose applications have been filed and accepted or who have submitted sufficient data on flavored vapes. The guidance, first reported by the New York Times, skips the usual draft and public comment process.
upi.comscience65 days ago
FDA Delays Enforcement on Some Flavored Vapes and Nicotine Pouches with Pending Applications
The agency announced it will not prioritize action against manufacturers with accepted applications that submitted sufficient public health data. The policy, issued without a draft for public comment, follows last week's authorization of two fruit-flavored vapes by Los Angeles-ba…