Apps

FDA Approves Rasonque for Metastatic PDAC; Price Concerns

The FDA approved Revolution Medicines' pancreatic cancer drug daraxonrasib, sold as Rasonque, the first therapy to target a genetic driver of the disease. In a trial of advanced/metastatic pancreatic cancer, median overall survival reached 13.2 months versus 6.7 with chemotherapy, signaling a potentially transformative option for patients who have received prior therapy.

United States Food and Drug Administration

5d

Health

FDA Approves Updated COVID-19 Vaccines Nationwide

The FDA has approved the updated Comirnaty XFG COVID-19 vaccine and related XFG-adapted formulations for fall 2026-2027, with immediate shipping to pharmacies, hospitals, and clinics for adults 65+ and younger individuals with underlying conditions at high risk. The approval, based on a broad body of clinical and real-world data, aligns with guidance to target current circulating variants and will extend access to the new vaccine across the United States.

3d

Health

FDA Authorizes Juul2 E-Cigarette

The FDA has authorized Juul Labs’ Juul2 e-cigarette system, including a device and 18 mg/mL tobacco- and menthol-flavored pods, and noted that a significant share of adult smokers switched from cigarettes to these products, with higher switching rates for menthol. Regulators emphasized that complete switching offers greater health benefits than dual use and that the agency approved these products because their population health benefits outweigh the risks, bringing the total FDA-authorized Juul items to 48 while signaling ongoing market expansion and future adult-focused flavor and strength applications.

3d

Health

HHS plans two new FDA deputy roles

The Department of Health and Human Services plans to create two new FDA deputy commissioner roles—one overseeing technology and the intersection of health and AI, and the other focused on drugs—with Jared Seehafer identified as a leading candidate for the technology post; no final decisions have been announced as the agency awaits Senate-confirmation for Heidi Overton as FDA commissioner. The moves signal a bid to reshape FDA leadership, with several acting positions still in flux.

Donald John Trump

6d

Health

FDA Extends Capricor Deramiocel BLA Review

Capricor Therapeutics announced that the FDA has extended the PDUFA target action date for its Deramiocel BLA for Duchenne muscular dystrophy from August 22, 2026 to November 22, 2026, following the submission of a BLA amendment with 24-month HOPE-3 open-label data and analyses supporting a refined indication focused on preserving upper limb function. The FDA classified the amendment as a major review and Capricor contends the extended data strengthen the case for addressing a significant unmet medical need in DMD, with HOPE-3 meeting its primary endpoint.

Duchenne muscular dystrophy

Aug 24, 2026

Health

FDA approves Alzheimer's blood test for age 40+

The FDA has cleared several Alzheimer’s blood tests, including PrecivityAD2 for adults 40 and older to aid diagnosis in symptomatic cognitive decline (not a general screening tool), and Elecsys pTau217 tests for those 55 and older to detect amyloid pathology and rule in or out Alzheimer's in various care settings, expanding access through Roche’s installed lab network and major providers. These tests, developed by Roche with Lilly and by other providers, aim to simplify early diagnosis and broaden eligibility for related treatments and care pathways.

United States Food and Drug Administration Eli Lilly and Company

Aug 24, 2026

Health

FDA approves Aletta robotic blood draw device

The FDA has authorized Aletta, the first standalone robotic device capable of drawing blood from an adult’s arm without hands-on operator intervention, to operate in outpatient settings under the supervision of a trained phlebotomist, with one supervisor able to oversee up to three devices. Clinical data show its success rates are comparable to or better than human phlebotomists and adverse events are generally mild and uncommon.

Aletta Jacobs

Aug 19, 2026

Health

FDA Approves Regeneron Pasatru for FOP

Regeneron's garetosmab, marketed as Pasatru, received FDA approval to treat adults with fibrodysplasia ossificans progressiva, becoming the second FDA-cleared therapy for FOP and the first to reduce clinician-assessed flare-ups. Driven by OPTIMA/phase 3 data showing about 90% reduction in new bone lesions over 56 weeks and substantial decreases in flare-ups, Pasatru competes with Ipsen's Sohonos and awaits EMA/Japan submissions, with price not disclosed.

Regeneron Pharmaceuticals fibrodysplasia ossificans progressiva

Aug 19, 2026

Politics

Trump Nominates Overton to FDA Chief

President Donald Trump has selected White House policy aide Heidi Overton to lead the Food and Drug Administration, with Bloomberg News first reporting and multiple outlets confirming the choice. Overton, a physician and former America First Policy Institute fellow, would replace interim chief Kyle Diamantas after Marty Makary’s resignation amid the agency’s turmoil.

Donald John Trump

Aug 19, 2026

Health

FDA GRAS Rule Expands Notification, Defines Ultraprocessed Foods

Health Secretary RFK Jr. is moving to close the GRAS loophole by requiring mandatory FDA notification for new food ingredients and enhancing transparency around additives, part of a broader push to overhaul the U.S. food system. While his administration touts regulatory reform and a planned ultraprocessed foods definition, industry opposition, political hurdles, and delays are anticipated as the rulemaking progresses.

Aug 7, 2026

Health

LYTENAVA Receives FDA Approval for Wet AMD

Outlook Therapeutics has won FDA approval for LYTENAVA (bevacizumab-vikg), making it the first and only ophthalmic bevacizumab formulation approved for treating wet AMD in the United States and a potential new standard of care developed specifically for the eye. The approval follows a lengthy regulatory history and positions LYTENAVA with anticipated market exclusivity under the BPCIA while signaling a major milestone for retina care.

United States of America United States Food and Drug Administration

Jul 24, 2026

Health

Roche cobas BV/CV vaginitis test FDA-cleared

Roche has received FDA 510(k) clearance for the cobas BV/CV assay, which detects bacterial vaginosis and Candida vaginitis from a single vaginal swab using real-time PCR, promising more accurate diagnoses than traditional methods. The test can be run on the cobas platform alongside other sexual-health assays and is intended for professional laboratory use, aiming to reduce misdiagnosis and speed appropriate treatment.

United States Food and Drug Administration North American

Jul 24, 2026

Health

FDA panel backs BPC-157 access, Hims shares surge

An FDA advisory panel recommended adding BPC-157 to the list eligible for pharmacy compounding, a move investors interpreted as a boost to Hims & Hers' telehealth and peptide offerings, with the stock jumping about 10–11% across reports. The company, valued around $8.1 billion, has faced insider selling in the past quarter, and regulators’ signaling comes as it positions itself in a growing peptide therapy market.

United States of America BPC-157

Jul 23, 2026

Business

Monopar Starts Rolling NDA for ALXN1840 Wilson Disease

Monopar Therapeutics has begun a rolling submission of a New Drug Application with the FDA for ALXN1840 to treat Wilson disease, with the first completed sections already filed under a rolling NDA process. The first-in-class albumin tripartite complex activator carries Fast Track, Orphan Drug, and Rare Pediatric Disease designations and aims to become the first novel-mechanism therapy approved for Wilson disease in decades.

United States Food and Drug Administration

Jul 22, 2026

Business

J&J Wins FDA De Novo OTTAVA System

Johnson & Johnson has received FDA De Novo clearance for its Ottava robotic surgical system, marking its entry into the U.S. market as a table-integrated, space-saving alternative aimed at general soft-tissue procedures. The company plans a selective U.S. rollout and ongoing global expansion, supported by an inguinal hernia trial and continued development of additional indications and regulatory approvals amid competition from Intuitive Surgical's established da Vinci platform.

United States of America United States Food and Drug Administration

Jul 22, 2026

Health

Cyclospora outbreak tied to Taylor Farms lettuce

Health officials led by RFK Jr. say the cyclosporiasis outbreak is under control with recalls linked to Taylor Farms and ongoing forensics, even as investigations continue. Meanwhile, Sen. Ossoff and others accuse the administration of weakening surveillance—cutting FoodNet’s coverage of Cyclospora and prompting questions about the outbreak’s source and current monitoring efforts.

Robert F. Kennedy, Jr.Jon Ossoff

Jul 20, 2026

Health

FDA Panel Recommends Loosening Peptide Compounding Rules

The FDA Pharmacy Compounding Advisory Committee is set to review seven peptide compounds, including BPC-157 and TB-500, to decide whether licensed pharmacies can make them, amid rising social-media-driven interest and largely unclear evidence of safety and effectiveness. Regulators caution the evidence base is limited as demand grows, with endorsements from public figures fueling interest and some users reporting benefits.

Jul 20, 2026

FDA Approves Rasonque for Metastatic PDAC; Price Concerns

FDA Approves Updated COVID-19 Vaccines Nationwide

FDA Authorizes Juul2 E-Cigarette

HHS plans two new FDA deputy roles

FDA Extends Capricor Deramiocel BLA Review

FDA approves Alzheimer's blood test for age 40+

FDA approves Aletta robotic blood draw device

FDA Approves Regeneron Pasatru for FOP

Trump Nominates Overton to FDA Chief

FDA GRAS Rule Expands Notification, Defines Ultraprocessed Foods

LYTENAVA Receives FDA Approval for Wet AMD

Roche cobas BV/CV vaginitis test FDA-cleared

FDA panel backs BPC-157 access, Hims shares surge

Monopar Starts Rolling NDA for ALXN1840 Wilson Disease

J&J Wins FDA De Novo OTTAVA System

Cyclospora outbreak tied to Taylor Farms lettuce

FDA Panel Recommends Loosening Peptide Compounding Rules

More headlines