FDA
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medpagetoday.comFDA 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.
NewsweekWawa 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.comFDA 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 IndependentFDA 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.
insurancejournal.comRaaw 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.
NewsweekFDA 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.
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.
StatFDA 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.govFDA 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.comFormer 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.comFormer 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.comFDA 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.
StatFDA 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…
StatActing 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…
StatU.S. Officials Press Germany to Raise Drug Prices in Bid to Lower American Costs
U.S. officials told the German ambassador that Germany should pay more for pharmaceuticals as part of a broader effort to reduce prices paid in the United States. The meeting involved the U.S. Trade Representative and a senior health department adviser. Separately, some U.S. biot…
thebalitimes.comFDA 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…
StatRegenxbio 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.comTrump 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.comFDA 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 NewsTrump 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.comBristol 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.comSupreme 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…
cnbc.comSupreme 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 BbcMarty 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…
StatFDA 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.
pharmaphorum.comAstellas to Restart Gene Therapy Trial for XLMTM Five Years After Patient Deaths Halted Program
Patients and families affected by the rare muscle disorder XLMTM are receiving a second chance at treatment as Astellas relaunches its gene therapy program. The move comes as fresh turmoil grips the top of the FDA with questions swirling over whether Commissioner Marty Makary wil…
foxnews.comMedicare Spending on Newly Approved Alzheimer’s Drugs Leqembi and Kisunla Far Below Initial Projections
Uptake of the recently approved intravenous Alzheimer’s medications has been far lower than anticipated, prompting Medicare to forecast no significant spending on Leqembi and Kisunla in 2026 or 2027. Two years ago the program projected billions of dollars annually on Leqembi alon…
upi.comFDA 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…
nbcnews.comTrump Removes FDA Commissioner Marty Makary
President Trump has approved a plan to dismiss FDA Commissioner Marty Makary after months of clashes over vaping approvals, vaccine policies, drug rejections and agency personnel turmoil. The move, first reported by the Wall Street Journal on May 8, 2026, would create another hig…
Nbc NewsTrump Considers Firing FDA Commissioner Marty Makary
President Trump is considering dismissing Dr. Marty Makary as commissioner of the Food and Drug Administration following frustration with his performance. A source familiar with the matter said no final decision has been reached. NBC News reported the development on May 9, 2026.
nypost.comTrump Approves Plan to Remove FDA Administrator Marty Makary
President Trump has approved a plan to oust FDA administrator Marty Makary amid criticism from anti-abortion groups over the agency's handling of mifepristone, drug approvals and vaccines. An administration official confirmed the decision to The Independent, though no action has…
naturalnews.comIllinois Company Recalls Nut and Corn Mixes Over Salmonella Concerns
John B. Sanfilippo and Son is recalling several snack products that contain dry milk powder previously recalled by California Dairies. The mixes were sold under the brand names Southern Style Nuts, Fisher, Squirrel Brand and Good & Gather at Target, other retailers, online and by…
nbcnews.comFDA Blocked Studies on Vaccine Safety and Efficacy
The Food and Drug Administration blocked studies demonstrating the safety of several vaccines, according to a New York Times report. Two of the withdrawn studies found that serious side effects from commonly used COVID vaccines were rare. A Department of Health and Human Services…
news.sky.comJohn B. Sanfilippo & Son Issues Voluntary Precautionary Recall of Several Snack Mixes Due to Supplier Ingredient
John B. Sanfilippo & Son announced a voluntary recall of six snack products on May 6, 2026, including Target's Good & Gather Mexican Street Corn Trail Mix, after a third-party seasoning mix tested positive for potential salmonella contamination from previously recalled dry milk p…
news18.comFDA Allows Sale of Fruit-Flavored Vapes After Policy Shift
The Food and Drug Administration has approved the sale of fruit-flavored electronic cigarettes. NPR interviewed former FDA tobacco chief Mitch Zeller on the agency's policy shift. The segment aired on Morning Edition on May 7, 2026.
fda.govFDA Hires 350 Staff After Cutting 3,500 Positions Last Year
Health and Human Services Secretary Robert F. Kennedy Jr. fired around 3,500 workers from the Food and Drug Administration last year. The agency is now seeking to hire more than 3,200 people, including scientific reviewers and investigators. As of late April, it had hired about 3…
prnewswire.comFederal Officials Detected Pfizer Bivalent Booster Stroke Signal in November 2022
Senate investigation details how health officials identified a safety signal for ischemic stroke in adults 65 and older linked to the Pfizer-BioNTech bivalent booster but continued recommending the shot. Internal records showed 226 stroke cases by February 2023 while messaging wa…
washingtonpost.comFDA Authorizes Glas E-Cigarettes With Age-Gating Technology, Including Fruit and Tobacco Flavors
The agency approved e-cigarettes in mango and blueberry flavors along with tobacco and menthol on May 6, 2026, citing the manufacturer’s age-gating technology. FDA Commissioner Marty Makary, who initially opposed the decision, said he was swayed by scientists’ assessment that the…
fda.govFDA Grants Fast-Track Voucher to Partner Therapeutics for Bile Duct Cancer Therapy
The US FDA has awarded a new fast-track voucher to Partner Therapeutics for its bile duct cancer drug. The designation is intended to expedite regulatory review of the treatment. It marks the latest use of the agency's voucher program for therapies targeting rare or serious condi…
upi.comFDA Withholds Some COVID-19 and Shingles Vaccine Studies Citing Scientific Standards
The Food and Drug Administration withdrew two COVID-19 vaccine studies accepted by medical journals and prevented submission of two Shingrix abstracts, according to The New York Times. HHS confirmed the actions and said the COVID studies were withdrawn because authors drew broad…
agriculture.einnews.comAldi Recalls Vanilla Crème Brûlée in Seven States Over Possible Glass Fragments
The U.S. Food and Drug Administration issued a Class II recall for Specially Selected Vanilla Crème Brûlée sold at Aldi stores. Lactalis Canada initiated the voluntary action after possible glass contamination was identified. The recall covers roughly 2,869 cases distributed to s…
washingtonpost.comFDA Authorizes First Fruit-Flavored E-Cigarettes
The Food and Drug Administration on May 5, 2026, approved mango and blueberry flavored vapes from Glas Inc. The products use age-gating technology that requires smartphone pairing and ID verification. The decision followed reported intervention by President Trump after initial op…
washingtonpost.comFDA Authorizes First Fruit-Flavored E-Cigarettes for Adult Smokers
The Food and Drug Administration has authorized the first fruit-flavored electronic cigarettes intended for adult smokers. The products, from Glas Inc., include mango and blueberry flavors along with two menthol varieties. The decision follows industry appeals and comes amid decl…
finance.yahoo.comFDA Shifts Remain Focus for Cell and Gene Therapy Industry at European Meeting
Cell and gene therapy developers gathered in Rome last week to discuss the sector's outlook in Europe. Conversations centered on recent FDA actions including a doubled rejection rate for such therapies since 2024 and the departure of the agency's top regulator for gene and cell t…
benzinga.comFDA Withdraws Studies That Found Rare Vaccine Side Effects
The U.S. Food and Drug Administration withdrew several studies concluding that Covid-19 and shingles vaccines had rare serious side effects, according to an HHS spokesperson. The studies, funded by taxpayer money, analyzed millions of patient records. FDA officials cited unsuppor…
cnbc.comFDA Withdraws Studies on Safety of COVID-19 and Shingles Vaccines
The U.S. Food and Drug Administration blocked the publication of research finding rare side effects from COVID and shingles vaccines. The studies were withdrawn due to broad conclusions not supported by data, amid broader efforts by the Trump administration to challenge vaccine r…
video.foxbusiness.comUtz Recalls Zapp's and Dirty Brand Potato Chips Nationwide Due to Salmonella Risk
Utz Quality Foods has initiated a voluntary recall of multiple varieties of Zapp's and Dirty brand potato chips sold nationwide. The recall stems from potential salmonella contamination in an ingredient, specifically dry milk powder in the seasoning. No illnesses have been report…
prnewswire.comFDA Commissioner Defends Rejection of Two Drugs
The FDA commissioner defended recent drug rejections in a CNBC interview, citing adherence to scientific reviews amid reports of agency turmoil. Criticism includes a high-profile denial of a melanoma treatment from Replimune and pressure from President Trump over vape approvals.…
Substrate placeholder — needs reviewa2 Milk Company Recalls Three Batches of Infant Formula Over Toxin Contamination
The a2 Milk Company has voluntarily recalled three batches of its a2 Platinum Premium USA infant formula due to the presence of cereulide, a toxin produced by certain bacteria. The affected products were sold online and in stores, with no reported illnesses. Consumers are advised…
Fox NewsAppeals Court Limits Mail Delivery of Mifepristone
A federal appeals court ruled to restrict access to mifepristone by prohibiting its distribution via mail, requiring in-person pickup at clinics. The decision, stemming from a challenge by Louisiana, overturns FDA regulations allowing telemedicine prescriptions. The ruling affect…
theyeshivaworld.comFDA Finds Dog Longevity Pill Likely Effective
Loyal, a startup founded by Celine Halioua, has developed a pill aimed at extending dogs' lives by improving insulin sensitivity. The FDA deemed the drug likely effective in February 2025 based on early data, with the company now pursuing full approval through a large clinical tr…
apnews.comFDA Detects PFAS in Half of Infant Formula Samples Tested
The U.S. Food and Drug Administration tested 312 infant formula samples and found five types of PFAS, with PFOS present in half. Experts noted low levels overall and highlighted PFAS-free options as evidence of feasible production without the chemicals. Two-thirds of U.S. infants…
White House photographer / Wikimedia (Public domain)J. Craig Venter Dies at 79
J. Craig Venter, who helped decode the human genome, has died at age 79. The FDA appointed an acting head for its biologics center and approved a new Alzheimer's drug. A biotech entrepreneur is launching an effort to scale bespoke medicines.
stockhead.com.auFDA Announces Initiative to Improve Clinical Trial Efficiency with Real-Time Data Review
The Food and Drug Administration announced efforts to enhance the efficiency of clinical trials by reviewing data in real time from studies by AstraZeneca and Amgen. The agency also sought public input on a potential pilot program incorporating artificial intelligence for tasks s…
Substrate placeholder — needs reviewFDA Proposes Revoking Approval of Amgen's Tavneos
The U.S. Food and Drug Administration proposed withdrawing approval for Amgen's drug Tavneos on April 28, 2026, citing lack of proven effectiveness and false statements in the original application. The agency reported 76 cases of drug-induced liver injury linked to the drug, incl…
Substrate placeholder — needs review50 Health Insurers Commit to Standardizing Prior Authorization for Key Services
Major health insurance companies, including UnitedHealthcare, Aetna and Cigna, committed to standardizing electronic prior authorization requests for services like orthopedic surgeries and imaging. The move spans commercial, Medicare Advantage and Medicaid managed care plans.
Substrate placeholder — needs reviewFDA Issues Priority Vouchers to Three Companies for Psychedelic Medication Reviews
The Food and Drug Administration announced on April 24, 2026, that it is issuing national priority vouchers to three companies to fast-track reviews of psychedelic medications. The companies are studying psilocybin for depression and methylone for PTSD. The move follows President…
theweek.comFederal Court Pauses U.S. Vaccine Advisory Panel Operations
A federal court has issued an order halting the work of the Advisory Committee on Immunization Practices, citing issues with member qualifications. The ruling disrupts recommendations for vaccines including those for COVID-19, flu, and RSV, and creates uncertainty for insurance c…