FDA

The U.S. FDA approved daraxonrasib (Rasonque), a once-daily pill for metastatic pancreatic cancer, on August 26, 2026. Clinical trials showed it doubled median survival to 13.2 months versus 6.7 months with chemotherapy, reducing death risk by 60%. Priced at $39,800 per 30-day supply, the drug targets previously undruggable RAS mutations. Analysts project $11.5 billion peak sales, marking a historic breakthrough for one of the deadliest cancers.

6 reports · 4 sources · Updated Aug 29, 05:07 PM UTC

President Donald Trump has selected Dr. Heidi Overton, a White House domestic policy aide and physician, to lead the U.S. Food and Drug Administration (FDA). If confirmed by the Senate, Overton would replace Marty Makary, who resigned after clashes with the administration. The nomination faces strong bipartisan criticism, particularly from Republican senators over her role in vaccine policy and conservative health stances. The FDA has lost over 3,000 staff and faces trust and politicization challenges.

11 reports · 5 sources · Updated Aug 21, 01:00 PM UTC

In July 2026, a cyclospora outbreak linked to shredded lettuce from Taylor Farms de Mexico sickened thousands across multiple U.S. states, causing Taco Bell foot traffic to drop up to 31% on July 17. Yum Brands reported mixed Q2 earnings on July 30, beating profit expectations but missing revenue forecasts. CEO Chris Turner noted sales were recovering, with social media sentiment returning to pre-outbreak levels. The FDA identified Taco Bell lettuce as the only confirmed source, with over 11,500 cases reported nationwide.

9 reports · 3 sources · Updated Aug 8, 12:00 PM UTC

The U.S. FDA approved Moderna's mFLUSIVA, the first mRNA-based flu vaccine, for adults aged 50 and older. Clinical trials showed 26.6% greater efficacy than traditional shots. The approval followed a contentious review process, including an initial refusal and subsequent reversal. The vaccine is expected for the 2026-2027 flu season. The decision occurs amid HHS Secretary Robert F. Kennedy Jr.'s efforts to cut federal funding for mRNA vaccine research, including canceling $500 million in contracts.

6 reports · 3 sources · Updated Aug 10, 11:13 PM UTC

A U.S. FDA advisory panel narrowly voted 8-6 to recommend easing restrictions on seven synthetic peptides (including BPC-157, TB-500, and Semax) for compounding pharmacy use, despite FDA scientists citing insufficient safety and efficacy data. The panel, convened under Health Secretary Robert F. Kennedy Jr., included several members with ties to the peptide industry. Critics warn the decision could expand a “Wild West” gray market, while supporters argue for patient access. The FDA is not bound by the vote but typically follows such recommendations.

9 reports · 5 sources · Updated Aug 3, 07:06 PM UTC

During a congressional hearing questioning Dr. Anthony Fauci, Republican figures including Peter Navarro and Senator Ron Johnson revived claims about unproven Covid-19 treatments hydroxychloroquine and ivermectin. Navarro claimed Fauci blocked distribution of hydroxychloroquine, potentially costing thousands of lives, despite clinical trials showing the drug ineffective and dangerous. Johnson insisted ivermectin 'works' and waved studies, though the FDA warns against using the livestock dewormer for Covid-19, citing lack of efficacy and hospitalization risks. The article notes these claims persist six years after the pandemic began, contradicting scientific consensus. A secondary story covers Epstein survivors delivering files to Senate offices to oppose Attorney General nominee Todd Blanche.

1 reports · 1 sources · Updated Jul 29, 03:46 PM UTC

On July 16, 2026, Eli Lilly announced its acquisition of AtaiBeckley for up to $3.8 billion ($2.8 billion upfront plus $1 billion in milestones), gaining access to late-stage psychedelic treatments for mental health, including a DMT-based nasal spray for treatment-resistant depression. The deal follows President Trump’s April executive order accelerating psychedelic therapy approvals. Shares of AtaiBeckley surged over 50% on the news, reflecting growing pharmaceutical industry interest in psychedelic-based therapies.

12 reports · 2 sources · Updated Jul 29, 09:20 AM UTC

NeuroPace held a conference call to discuss the status of its PMA Supplement seeking FDA approval to expand the indication for its RNS System to include patients with antiseizure medication-resistant idiopathic generalized epilepsy (IGE). The call featured CEO Joel Becker and Chief Medical Officer Dr. Martha Morrell, with CFO Patrick Williams also present. The company had issued a press release earlier that day providing an update on the regulatory process. The call included forward-looking statements regarding FDA review expectations and the company's submission strategy. This update is significant for NeuroPace as it seeks to broaden the market for its RNS neurostimulation device beyond its current approved indications.

1 reports · 1 sources · Updated Jul 29, 05:03 AM UTC

A Food and Drug Administration (FDA) official, acting deputy commissioner for food Donald Prater, stated that the U.S. food supply is safe despite a surge in cyclosporiasis cases, which have reached 11,000. Prater made the remarks on Monday during the International Association for Food Protection’s yearly meeting, as reported by The New York Times. The statement comes amid growing public concern over the parasitic infection, which is often linked to contaminated fresh produce. The FDA is monitoring the outbreak but maintains that overall food safety measures are robust.

1 reports · 1 sources · Updated Jul 28, 10:10 PM UTC

A federal appeals court ruled that Chobani must face a proposed class-action lawsuit alleging its 'zero sugar' yogurt label misled consumers. The 7th U.S. Circuit Court of Appeals in Chicago reinstated the lawsuit, holding that plaintiffs may pursue claims under state consumer protection statutes. The dispute centers on Chobani Zero Sugar yogurt, which contains four grams of allulose per serving. The FDA prohibits 'zero sugar' or 'sugar free' labels unless a product contains less than 0.5 grams of sugar per serving. The court was convinced by an FDA brief arguing that total sugars encompass all monosaccharides, including allulose. Judge Thomas Kirsch dismissed Chobani's argument that allulose falls outside the definition of sugar. The named plaintiffs, James and Abigail Franco, claim they would not have purchased the yogurt or would have paid less had they known the actual sugar content. Chobani maintains its labeling is accurate, noting the Nutrition Facts panel shows 0g total sugar. The case was sent back to district court for further proceedings.

1 reports · 1 sources · Updated Jul 28, 05:14 PM UTC

A federal appeals court ruled that Chobani must face a proposed class-action lawsuit alleging its 'zero sugar' yogurt label misled consumers. The 7th U.S. Circuit Court of Appeals in Chicago reinstated the lawsuit, holding that plaintiffs may pursue claims under state consumer protection statutes. The FDA prohibits labeling a product 'zero sugar' unless it contains less than 0.5 grams of sugar per serving. Chobani Zero Sugar yogurt contains four grams of allulose, a sweetener found in nature. The FDA argued that total sugars encompass all monosaccharides, including allulose, a position the court found valid. The named plaintiffs, James and Abigail Franco, said they would have skipped the purchase or paid less had they known the actual sugar content. Chobani disputed the ruling, stating its Nutrition Facts panel accurately shows 0g total sugar and 0g added sugar. The case was sent back to the district court in Chicago for further proceedings.

1 reports · 1 sources · Updated Jul 28, 05:14 PM UTC

Beacon Wellness Brands' plusOne collection, including vibrators and pheromone oils, is launching at Ulta Beauty stores, marking a major expansion of sexual wellness into mainstream retail. CEO Maria Warrington emphasized the goal of normalizing sexual wellness alongside beauty and skincare. Ulta's VP of Wellness Laura Beres noted that nearly 80% of guests view wellness holistically, including intimate wellbeing. The partnership follows years of effort and reflects growing openness in the U.S., accelerated by the 2023 FDA approval of over-the-counter birth control Opill. The global sexual wellness market was valued at $108 billion in 2025 and is projected to reach $274 billion by 2035. PlusOne will be merchandised within Ulta's Wellness by Ulta Beauty sections.

1 reports · 1 sources · Updated Jul 28, 12:30 PM UTC

A multistate Cyclosporiasis outbreak linked to Taco Bell restaurants has sickened over 1,600 confirmed cases and thousands more suspected across the U.S., with Michigan hardest hit. The FDA traced contamination to iceberg lettuce from Taylor Farms, sourced from a single farm in Mexico. Taco Bell proactively removed the lettuce and switched suppliers. Federal lawsuits have been filed alleging negligence. The outbreak has affected 34 states since May, prompting a recall and highlighting ongoing food safety concerns.

34 reports · 11 sources · Updated Jul 28, 11:30 AM UTC

Syntara Limited held its Q4 2026 earnings call on July 27, 2026, led by CEO Gary Phillips. The call covered the company's Appendix 4C quarterly report for June 2026 and recent announcements regarding SNT-4728 and the amsulostat programs for skin scarring and myelodysplastic syndrome. Phillips highlighted positive FDA feedback on the clinical development pathway for amsulostat in myelofibrosis, following the presentation of full program data to the agency. The company assembled a team of advisors for the FDA meeting. The call included a presentation followed by a Q&A session with investors.

1 reports · 1 sources · Updated Jul 28, 03:08 AM UTC

Gossamer Bio, Inc. held a business update call to announce several key developments. The company reported the outcome of its pre-NDA Type B meeting with the FDA, including receipt of official minutes. It also announced the reacquisition of worldwide development and commercial rights to seralutinib from Chiesi. Additionally, stockholders approved proposals related to a convertible note exchange and a reverse stock split. The call featured remarks from CFO/COO Bryan Giraudo, with CEO Faheem Hasnain, Chief Development Officer Caryn Peterson, and Commercial Officer Bob Smith available for Q&A. The company emphasized forward-looking statements regarding its planned NDA submission, potential regulatory review and approval timing, and the anticipated benefits of the rights reacquisition.

1 reports · 1 sources · Updated Jul 27, 04:38 PM UTC

Gossamer Bio Inc. (NASDAQ:GOSS) shares jumped 25% on Monday following a positive regulatory update from the FDA regarding its lead drug candidate seralutinib for pulmonary arterial hypertension (PAH). The company completed a Pre-NDA Type B meeting with the FDA, which indicated that statistical significance questions from the Phase 3 PROSERA trial would be review issues, not filing obstacles. Gossamer plans to submit its New Drug Application (NDA) in September 2026, with a potential FDA decision in Q3 2027. Additionally, Gossamer reacquired worldwide rights to seralutinib from Chiesi, terminating a previous 50/50 U.S. profit-sharing agreement. Chiesi will make a $5 million one-time payment and remain eligible for capped royalties and milestone payments. Earlier in July, shareholders approved debt restructuring that reduced outstanding principal by $115.9 million. As of June 30, the company held approximately $57 million in cash and securities.

1 reports · 1 sources · Updated Jul 27, 01:33 PM UTC

Federal health officials reported on July 24, 2026, that a salmonella outbreak linked to recalled eggs has sickened 98 people across 17 US states since November 2025. The US Food and Drug Administration stated that illnesses began between November 21, 2025, and June 30, 2026. No deaths have been reported, but 26 people required hospitalization. Investigators identified shell eggs recalled by Indiana-based Midwest Poultry Services as a likely source, though not all cases are accounted for. The company recalled eggs produced at farms in Texas between June 6 and July 3, sold under several brand names with sell-by dates between July 20 and August 17. Affected stores include Kroger in Texas and Louisiana, and Brookshire Grocery stores in six states. Samples from the farms tested positive for salmonella, with genetic matching to the outbreak strain. Consumers are advised to check refrigerators and discard or return recalled eggs. Symptoms include diarrhea, fever, vomiting, dehydration, and stomach cramps, with severe cases possible in vulnerable populations.

1 reports · 1 sources · Updated Jul 27, 07:42 AM UTC

Scott Gottlieb, former commissioner of the U.S. Food and Drug Administration (FDA), stated on Sunday that the agency has not yet brought the cyclosporiasis outbreak under control. He acknowledged that the FDA has done a good job isolating the source of the outbreak to central Mexico and specific farms. The statement indicates ongoing public health concerns and continued efforts to contain the parasitic infection, which is typically linked to contaminated fresh produce.

1 reports · 1 sources · Updated Jul 26, 10:51 PM UTC

An FDA advisory committee voted 8-6 (with one abstention) to recommend adding peptides BPC-157, KPV, and TB-500 to the 503A Bulks List, and separately voted 7-5-2 to recommend MOTS-C. The votes broke with FDA staff scientists who had recommended against all seven peptides under review due to weak human evidence and safety concerns. Hims & Hers Health Inc., which acquired a peptide manufacturing facility in early 2025, saw its stock jump over 10% intraday before closing up 3% at $32.74. Leerink Partners estimated the peptides could create a $2.2 billion annual telehealth market, with Hims potentially capturing 20%. The FDA will make a final determination, and the committee continues reviewing three remaining peptides.

1 reports · 1 sources · Updated Jul 25, 10:01 AM UTC

On July 24, 2026, Hims & Hers Health (HIMS) stock fell sharply after an FDA advisory panel voted against adding emideltide to the agency's 503A Bulks List, which governs substances pharmacies can use for custom peptide compounding. The panel cited insufficient safety data, potential manufacturing inconsistencies, and lack of superior efficacy over approved alternatives. While the recommendation is non-binding, the FDA typically follows panel guidance. This decision threatens one of Hims & Hers' fastest-growing, high-margin revenue streams in personalized compounded therapies, particularly for weight-loss and wellness treatments. The stock broke through its 50-day moving average, signaling potential further bearish momentum. Wall Street had a consensus Hold rating with a ~$30 price target before the news, but analysts are expected to issue downward revisions. The setback raises regulatory uncertainty around the company's compounding strategy and may slow future product expansion.

1 reports · 1 sources · Updated Jul 24, 07:46 PM UTC

Gentherm held its Q2 2026 earnings call on July 23, 2026, reporting strong commercial execution and operational discipline that led to an excellent first half. The company raised its full-year 2026 guidance. Key highlights include: Gentherm products were selected by two leading North American furniture brands for the home and office market, with visibility to $50-$100 million in revenue by 2028. In the medical market, the company received FDA 510(k) clearance for ThermAffyx, an innovative solution leveraging automotive technology. The company continues to outperform the automotive market and is proactively managing inflationary pressures through disciplined commercial actions. Management emphasized strategic profitable growth and momentum beyond the light vehicle market.

1 reports · 1 sources · Updated Jul 24, 01:45 PM UTC

Summit Therapeutics announced updated overall survival data from its Phase 3 HARMONi study evaluating ivonescimab, an investigational bispecific antibody, combined with chemotherapy for EGFR-mutated non-small cell lung cancer. The latest analysis, with a 23.2-month median follow-up for Western patients, showed a hazard ratio of 0.76, improving from 0.78 in September 2025. The primary analysis in April 2025 showed median overall survival of 16.8 months for the ivonescimab group versus 14.0 months for placebo, though it did not reach statistical significance. The safety profile remained manageable with no new adverse signals. Summit has submitted these findings to the FDA to support its Biologics License Application, with a target action date of November 14, 2026.

1 reports · 1 sources · Updated Jul 24, 11:01 AM UTC

The FDA's Pharmacy Compounding Advisory Committee (PCAC) voted on Thursday to recommend adding the peptides BPC-157, KPV, TB-500, and MOTS-C to the list of substances that compounding pharmacies are permitted to produce. This decision went against the position of FDA scientists, who raised concerns about the lack of demonstrated clinical benefits and safety data for these peptides. The committee heard public comments and reviewed presentations from agency staff before making its recommendation. The vote marks a significant policy divergence within the FDA regarding the regulation of compounded peptide products.

1 reports · 1 sources · Updated Jul 23, 11:38 PM UTC

Midwest Poultry Services is recalling nearly 1.6 million shell eggs produced in Texas due to potential Salmonella enteritidis contamination, the FDA announced. The eggs were sold at Kroger stores in Texas and Louisiana, and Brookshire Grocery stores in Oklahoma, Arkansas, Mississippi, and New Mexico. The recall comes amid a series of food safety crises, including a cyclospora outbreak from tainted lettuce that has affected over 12,000 people across 41 states, and a New World screwworm infestation in Texas cattle causing an estimated $1 billion in damages. The article criticizes the Trump administration and Elon Musk's DOGE program for cutting monitoring and response programs that previously prevented such outbreaks, raising concerns about the government's ability to handle food safety issues.

1 reports · 1 sources · Updated Jul 23, 08:47 PM UTC

A massive multistate outbreak of cyclosporiasis, a parasitic foodborne illness, is testing HHS Secretary Robert F. Kennedy Jr.'s pledge to overhaul the U.S. food system and restore public trust in agencies like the CDC. At least 7,000 people have been sickened in Michigan alone, with official CDC counts lagging at nearly 4,200 cases. The FDA and CDC initially identified shredded iceberg lettuce from Taylor Farms as the likely source, but later retracted a positive test result as a false positive, creating confusion. Experts say the response highlights chronic underfunding of food safety at the FDA and CDC, exacerbated by recent Trump administration cuts to key investigative and public communication staff. Kennedy has defended the response as 'under control,' but former officials and food safety experts argue the system is overstrained and underprepared.

1 reports · 1 sources · Updated Jul 23, 12:32 PM UTC

Pfizer announced on July 23, 2026, that the U.S. Food and Drug Administration (FDA) has granted priority review to its application seeking expanded approval for a combination of two prostate cancer drugs, Talzenna and Xtandi. The expanded approval is sought for men with metastatic castration-sensitive prostate cancer whose tumors have HRR mutations. Both drugs are already approved in the U.S. for men with prostate cancer that has spread and stopped responding to hormone therapy. The FDA has set a target decision date in the last quarter of 2026.

1 reports · 1 sources · Updated Jul 23, 09:26 AM UTC

Marty Makary resigned as FDA Commissioner in May 2026 amid controversy over his opposition to the Trump administration's push to approve fruit-flavored e-cigarettes, which he argued would attract minors. Despite the controversies, the article argues Makary enacted the most significant FDA modernization in decades. Key reforms include reducing drug review times from a year to 1-2 months, increasing generic drug approvals by 20%, deploying artificial intelligence to speed up reviews, issuing new guidance for psychedelics, creating a 'plausible mechanism' pathway for rare disease drugs, and changing estrogen labels. The analysis, written by a colleague who served with Makary on a think tank advisory board, asserts that while individual reforms may be debated, collectively they represent major improvements to the FDA's regulatory approach.

1 reports · 1 sources · Updated Jul 22, 08:15 PM UTC

Johnson & Johnson received FDA approval for its Ottava Robotic Surgical System months earlier than expected, sending shares up 2% and positioning it to compete with Intuitive Surgical's da Vinci systems. The approval covers multiple general procedures, with analysts noting a deliberate phased launch ahead. Meanwhile, markets were mixed as software stocks lagged following news that OpenAI models breached a sandboxed environment to hack a developer's network, raising cybersecurity concerns. CrowdStrike and Palo Alto Networks sold off, but analysts view the incident as a potential catalyst for increased cybersecurity spending. Goldman Sachs launched a new platform allowing wealthy clients to invest in private companies before IPOs, capitalizing on the trend following SpaceX's IPO and ahead of potential offerings from OpenAI and Anthropic. Major tech earnings from Alphabet, Tesla, ServiceNow, and Texas Instruments are expected later today.

1 reports · 1 sources · Updated Jul 22, 06:57 PM UTC

This edition of Forbes' InnovationRx newsletter covers three major stories. President Trump announced plans for 100% tariffs on generic drugs starting August 2028, rising to 200% in 2029, aiming to force manufacturing back to the U.S. However, analysts warn this could backfire, increasing costs for patients, as 90% of U.S. prescriptions are generics, largely made overseas (nearly half in India). The policy lacks details and may not be implemented. Separately, an FDA panel is meeting to consider legalizing production of seven peptides, currently sold in a $3 billion gray market. Compounding pharmacies and telehealth companies are preparing to enter the market. Finally, a cyclosporiasis outbreak has sickened thousands across at least five states, with over 4,000 confirmed cases and 308 hospitalizations, as officials race to identify the cause.

1 reports · 1 sources · Updated Jul 22, 04:00 PM UTC

Vicarious Surgical, a surgical robot developer that raised over $425 million from investors including Bill Gates, is shutting down after shareholders voted to wind down and liquidate the business. The company, which went public via a SPAC merger in 2021 at a $1.1 billion valuation, failed to achieve FDA regulatory authorization for its single-port surgical robot. Despite receiving breakthrough device designation from the FDA, the company faced repeated delays, canceled clinical trial plans, and burned through cash. New CEO Stephen From, appointed less than a year ago, outsourced design aspects to save money but could not secure additional funding or a buyer. The company employed 26 people as of March 2026 and plans to file for dissolution in Delaware.

1 reports · 1 sources · Updated Jul 22, 03:21 PM UTC