Food and Drug Administration

Happy Health, founded by Dustin Freckleton, developed an AI-powered smart ring to aid physicians in diagnosing conditions like sleep apnea. The company has raised $75 million since 2019 and provides a platform that collects biometric data while users sleep and connects them to a physician network for diagnosis and treatment plans.

An executive order from President Donald Trump calls for separating combination shots, such as the measles, mumps, and rubella vaccine, into individual injections, requiring drugmakers to revive vaccines unused in decades. Public health experts criticize this plan, stating there is no scientific basis for the change, noting that implementing it would require pharmaceutical companies to conduct large studies and overhaul manufacturing facilities.

A plan proposed by Donald Trump calls for separating combination vaccines, such as MMR, into individual shots and spacing out vaccinations, which would require drugmakers to revive unused vaccine formulations and build new manufacturing plants. Public health experts argue that this policy lacks scientific basis and would impose significant financial and logistical challenges on parents and providers. Implementing the changes could take years and involve massive research and development by pharmaceutical companies.

The Food and Drug Administration expanded its investigation into a Cyclospora outbreak linked to recalled iceberg lettuce. This investigation expanded after the confirmation of two deaths associated with the outbreak. The illness was initially identified in July among people who ate shredded iceberg lettuce at Taco Bell restaurants.

A salmonella outbreak linked to jalapeno peppers from Mexico has sickened 345 people across 27 U.S. states, prompting a product recall and investigations by the CDC and FDA.

Fifteen U.S. states are now linked to a cyclospora outbreak tied to iceberg lettuce, with investigations pointing to Taylor Farms as the source. The CDC reports over 25,000 cases nationwide, including two deaths in Michigan, and the FDA is tracking five separate cyclospora outbreaks.

The FDA is expected to decide on approving the first mRNA flu vaccine. The vaccine could mark a new approach to influenza immunization.

Federal health officials from the FDA and CMS met with 10 technology companies, including Microsoft AI and Amazon One Medical, to discuss clinical artificial intelligence adoption and regulation. The July 8 'clinical AI demo day' aimed to provide regulators firsthand experience with AI doctor technology and shape policy on health AI.

The article discusses the U.S. Army's missile stockpiles and the Food and Drug Administration's consideration of a flu vaccine utilizing mRNA technology.

Chipotle Mexican Grill removed jalapeños from some restaurants due to a potential link to a salmonella outbreak under investigation by health officials. The Minnesota Department of Health reported 110 cases tied to Mexican-style restaurants, with jalapeños as the suspected source, though contaminated food may still be served elsewhere.

The FDA authorized four flavored nicotine pouches (Rich Berry 2 mg, Cappuccino 2 mg, Cappuccino 4 mg, Autumn Spice 2 mg) from Helix Innovations LLC as part of its tobacco review pilot program.

Chipotle Mexican Grill removed jalapeños from some restaurants amid a salmonella outbreak investigation, with Minnesota health officials confirming 110 cases linked to jalapeños at multiple Mexican-style quick-service restaurants. The FDA is conducting a traceback investigation, and Chipotle's stock dropped 9% following the announcement.

Lidl has expanded a multi-state recall to include two types of Eridanous Shortbread Cookies due to missing English ingredient lists and allergen declarations. The recalled products, distributed in 10 states and Washington, D.C., pose a risk to individuals allergic to wheat, soy, milk, egg, or coconut. Consumers are advised to return or discard the cookies.

A new analysis questions the justification for expanded exemptions of orphan drugs from Medicare pricing negotiations under the Orphan Cures Act, which broadened protections for drugs with multiple rare disease indications. The law delays price negotiation timelines for these drugs, despite concerns they may not warrant such exemptions.

A person with type 1 diabetes has improved their glucose control using non-FDA-approved open-source software instead of FDA-regulated systems. The software, developed by dissatisfied users, fine-tunes insulin delivery and has allowed the individual to meet health guidelines they previously struggled to achieve.

The California Supreme Court ruled that Gilead Sciences is not liable for negligence claims in a class action accusing the company of delaying the development of a safer HIV drug (TAF) to prolong profits from its existing drug (TDF). The court concluded manufacturers do not owe a duty of care for nondefective drugs when deciding to commercialize alternative treatments.

Michigan has reported the first deaths linked to a multistate cyclosporiasis outbreak, with two individuals having significant underlying health conditions. The CDC reports over 6,700 cases across 45 states and 400 hospitalizations. The FDA is investigating the source of a second wave of illnesses after an earlier outbreak was linked to iceberg lettuce from a Mexican farm.

The first deaths from a cyclosporiasis outbreak in Michigan have been reported, with two residents who had significant underlying health conditions succumbing to the illness. Over 11,000 cases have been confirmed, and the FDA suspects tainted iceberg lettuce as the source.

Medicare is eliminating alternative pathways that allowed FDA-designated 'breakthrough' medical devices to qualify for supplemental payments without proving clinical improvement. The Centers for Medicare and Medicaid Services finalized a rule requiring such devices to demonstrate substantial clinical improvement starting in fiscal year 2028.

Nearly 12 million bottles of Rohto eye drops have been recalled by the FDA due to potential sterility issues. The recall urges Americans to stop using the product immediately.

Nearly 12 million bottles of Rohto eye drops have been recalled due to potential sterility issues, as reported by the FDA. The recall urges immediate discontinuation of the product.

The Trump administration's efforts to restructure health leadership face challenges as vaccine policy controversies resurface. Key personnel changes in the Department of Health and Human Services (HHS), including the appointment of Chris Klomp, contrast with ongoing issues at the FDA and CDC, while Senate confirmations for health roles encounter mixed outcomes.

The author shares their experience of being diagnosed with limb girdle muscular dystrophy (LGMD) and highlights the lack of available treatments or cures. They emphasize the urgency for faster drug development due to the irreversible muscle loss caused by delays. The article notes advancements in gene therapies and FDA opportunities to modernize rare disease treatments.

The article discusses the FDA's inconsistent approaches to Duchenne muscular dystrophy drugs, potential changes in drug company leadership, and Adam's conversation with a recruiter. It references a podcast episode exploring these topics.

The FDA initially identified cyclospora on Taylor Farms' shredded iceberg lettuce, leading to a voluntary recall, but later retracted the finding as a false positive. The CDC linked the outbreak to nine U.S. states with nearly 2,000 cases, noting challenges in tracking due to home-managed symptoms and inconsistent public health communication. Climate change's potential role in the outbreak remains debated among experts.

The Bombay High Court overturned the Food and Drug Administration's (FDA) suspension of a hotel's licence, ruling that the presence of two insects did not justify the action given the overall satisfactory hygiene compliance report. The court emphasized the need for proportionality in regulatory enforcement.

The Bombay High Court has requested the Maharashtra government to provide details of FDA inspections at state-run canteens and eating places. The FDA, led by Food Safety Commissioner Tukaram Mundhe, is conducting a crackdown on food operators violating safety standards.

Grocery store Lidl recalled Eridanous Shortbread Cookies with Chocolate Truffle Coating & Apricot Filling due to undeclared allergens, including wheat, soy, milk, and egg. The Food and Drug Administration warned that the cookies' foreign-language labels omitted these allergens, and customers with allergies are advised not to consume them.

The FDA classified a recall of over 11 million cartons of Rohto Cooling Eye Drops as a Class II recall due to potential sterility issues. The recall, initiated by Rohto-Mentholatum (Vietnam-based company), affects multiple variants of the eye drops, with the FDA noting temporary or reversible health risks if used.

A large Cyclospora outbreak linked to contaminated iceberg lettuce has infected over 11,000 people across 40 states, exposing weaknesses in the U.S. food safety system. Health experts warn that reduced staffing and resources at agencies like the FDA and CDC, along with public distrust, threaten efforts to promote whole foods consumption.

FDA staff have reiterated concerns about insufficient data to support approval of Replimune’s investigational skin cancer treatment RP1. The agency criticized a single-arm trial combining RP1 with Opdivo, arguing it fails to establish the drug’s efficacy or systemic benefits, while Replimune claims ethical and feasibility challenges prevent a placebo-controlled study.

The FDA has classified a nationwide recall of Levothyroxine, a thyroid medication, as a Class II recall due to being 'subpotent.' Major Pharmaceuticals, based in Dublin, Ohio, issued the voluntary recall on July 13, with the FDA officially marking it Class II on July 17.

A growing trend of microdosing GLP-1 drugs like Ozempic and Wegovy is spreading via social media, with users altering doses to reduce costs and side effects. However, this practice lacks FDA approval and clinical testing, posing unpredictable health risks. Pharmacist Sue Ojageer warns that self-directed microdosing bypasses medical supervision and may not be safer than standard prescriptions.

Scott Gottlieb, the former FDA commissioner, stated the FDA has not yet controlled the cyclosporiasis outbreak. Cyclospora, the parasite causing the illness, remains a public health concern.

Scott Gottlieb, former FDA commissioner, criticized Taylor Farms for contacting the White House to delay a recall announcement linked to a cyclospora outbreak. The Wall Street Journal reported Taylor Farms sought to delay the recall while federal investigators were linking the company to the outbreak.

The FDA approved a new over-the-counter pain relief combining Tylenol and Naproxen. Tylenol disrupts pain signals immediately, while Naproxen targets inflammation.

An advisory committee for the Food and Drug Administration has narrowly voted to add six peptides to a drug compounding list.

Federal health officials expanded the cyclospora parasite outbreak investigation to four additional states (Illinois, Kansas, Oklahoma, Pennsylvania), linked to shredded lettuce from Taco Bell and Taylor Farms. The outbreak now includes 1,947 cases with 98 hospitalizations, though the true count is likely higher. Investigations into supply chains and a separate outbreak in 72 people continue.

Federal health officials expanded the cyclospora outbreak investigation to four more states, including Illinois, Kansas, Oklahoma, and Pennsylvania, linked to shredded lettuce from Taco Bell. The CDC reported 1,947 cases and 98 hospitalizations, with Taylor Farms recalling lettuce from central Mexico. Mexican health officials found no parasite in lettuce or water from the affected plant.

A federal judge ruled that FDA restrictions on mifepristone, an abortion medication, are arbitrary and capricious, ordering the Trump administration to reconsider the restrictions. The judge affirmed the drug's safety and cited growing barriers to abortion access.