FDA Press Releases
Last published 2d ago
- 2d agoFDA Approves First Factor Xla Inhibitor to Help Prevent Stroke in Certain Adults at High RiskFDA Press ReleasesFDA today approved Sunharbo (asundexian) 50 mg tablets, the first factor XIa (FXIa) inhibitor for use in combination with antiplatelet therapy to reduce the risk of stroke in adults following a recent mild-to-moderate non-cardioembolic ischemic stroke or a high-risk transient ischemic attack.
- 6d agoFDA Grants Accelerated Approval to a New Treatment for Head and Neck Squamous Cell CarcinomaFDA Press ReleasesThe U.S. Food and Drug Administration today granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for the treatment of adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed on or after platinum-based chemotherap
- 1w agoFDA Provides Clarity to Support Cell and Gene Therapy Development and QualityFDA Press ReleasesThe U.S. Food and Drug Administration today issued final guidance for manufacturers of cellular and gene therapy (CGT) products to implement a comprehensive, science- and risk-based plan for making sure their products meet potency standards.
- 1w agoFDA Approves First Plasmid DNA-based Immunotherapy for Adults with Recurrent Respiratory PapillomatosisFDA Press ReleasesThe U.S. Food and Drug Administration today granted accelerated approval for Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for treatment of adults with recurrent respiratory papillomatosis (RRP).
- 2w agoFDA Launches New Program to Advance Neuroscience Medical Product DevelopmentFDA Press ReleasesFDA announces the launch of the Neuroscience Advancement and Innovation Nexus (NAIN), a new agency program aligned with the Trump Administration’s efforts to accelerate medical innovation and deliver breakthrough treatments.
- 3w agoFDA Approves First-of-Its-Kind Chronic Hepatitis B TreatmentFDA Press ReleasesFDA today approved Hibsago (bepirovirsen) injection, in combination with existing antiviral therapy, to treat chronic hepatitis B virus (HBV) infection in certain adults without cirrhosis.
- 3w agoFDA Approves Once-Weekly Generic Hormone Therapy Patch for WomenFDA Press ReleasesToday, the U.S. Food and Drug Administration approved the first generic of Climara Pro (estradiol and levonorgestrel transdermal system, 0.045 mg per day/0.015 mg), a transdermal hormone therapy patch for women with an intact uterus applied once a week.
- 3w agoFDA Issues Final Guidance on Prescription Drug Apps and SoftwareFDA Press ReleasesThe U.S. Food and Drug Administration today released final guidance establishing a clear framework for how drug companies can develop, distribute, and label apps used alongside their prescription medicines.
- 3w agoFDA Approves Immunotherapy That May Allow Certain Patients with Rectal Cancer to Avoid Chemotherapy, Radiation and SurgeryFDA Press ReleasesThe U.S. Food and Drug Administration today granted accelerated approval for a new use of the immunotherapy Jemperli (dostarlimab-gxly) that may allow some patients with locally advanced rectal cancer to avoid common treatments that can have a lasting impact on their daily life.
- 4w agoFDA Launches the Rare Disease Framework Initiative to Develop a Holistic, Fit-For-Purpose Framework for Rare Disease Drug DevelopmentFDA Press ReleasesThe U.S. Food and Drug Administration, a division within the U.S. Department of Health and Human Services (HHS), today announced the Rare Disease Framework Initiative to reimagine the development of drugs and biologics for rare diseases.
- 4w agoFDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder CancerFDA Press Releases
- 1mo agoFDA Seeks Public Input to Support Ibogaine ResearchFDA Press Releases
- 1mo agoEWFDA Approves First Heart Valve Designed to Grow with ChildrenFDA Press ReleasesThe U.S. Food and Drug Administration today approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for pediatric patients with congenital pulmonary valve disease. This innovative device may reduce the need for repeat open-heart surgeries in children with heart defects, reflecting the Trump Administration’s commitment to bringing breakthrough medical technologies to ...
- 1mo agoFDA Launches Nationwide Effort to Expand Scientific Expertise and Consumer Voices to Advisory CommitteesFDA Press Releases
- 1mo agoFDA Investigation Leads to Charges Against Two Indian Nationals Involved in Transnational Counterfeit Drug Distribution SchemeFDA Press ReleasesThe U.S. Attorney’s Office for the Middle District of Florida and the Criminal Division of the U.S. Department of Justice today announced federal charges against Swapnadip Roy, 33, and Vicky Ramancha, 37, both Indian nationals. The two individuals have been charged with conspiracy and smuggling related to an alleged transnational counterfeit prescription drug distribution scheme. The U.S. Food and ...
- 1mo agoFDA Approves First Treatment for MCT8 DeficiencyFDA Press Releases
- 1mo agoFDA intends to evaluate changes to the PMTA regulatory frameworkFDA Press ReleasesFDA is carefully reviewing its experience implementing the Premarket Tobacco Product Application (PMTA) rule, as well as recent judicial developments, including a federal lawsuit filed in the U.S. District Court for the Northern District of Texas challenging the current regulatory framework. Based on FDA’s learned experience implementing the 2021 rule, the widespread development of an illicit and ...
- 1mo agoFederal Court Enters Consent Decree Against Gold Star Distribution, Inc. Following Persistent Insanitary Warehouse ConditionsFDA Press ReleasesA U.S. Food and Drug Administration investigation resulted in a federal court order, dated Sept. 21, 2026, stopping a warehouse operator from distributing FDA-regulated products including food, drugs, medical devices, and cosmetics until it fixes its operations to meet federal legal requirements.The U.S. District Court for the District of Minnesota entered a consent decree of permanent injunction ...
- 1mo agoFDA Updates Regulations to Advance Innovative Alternatives to Animal TestingFDA Press ReleasesThe U.S. Food and Drug Administration today issued a direct final rule that updates its regulations to clarify that non-animal methods can be used where appropriate for testing the safety of drugs and biological products intended for human use before they’re tried in humans.The update reflects advances in science and technology that have expanded the range of testing options available in human dru ...
- 1mo agoJBSSMSMRAREFDA Approves First Gene Therapy for Pediatric Patients with Sanfilippo Syndrome Type AFDA Press ReleasesThe U.S. Food and Drug Administration today approved Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with mucopolysaccharidosis type IIIA (MPS IIIA), also known as Sanfilippo syndrome type A., MPS IIIA is a rare inherited disease that progressively damages the brain and nervous system, causing children to lose cognitive, language and other developmental abiliti ...
- 1mo agoFDA Launches Expedited IND Pilot, Begins Accepting ApplicationsFDA Press Releases
- 2mo agoFDA Takes Steps to Maintain Newborn Access to Life-Saving Starter Nutrition ProductsFDA Press ReleasesThe U.S. Food and Drug Administration today announced it is taking action, consistent with the Trump administration’s commitment to protecting vulnerable patients and maintaining access to critical medical products, to help address a potential supply gap of neonatal starter parenteral nutrition (PN). These products provide essential nutrients through an IV to premature and critically ill newborns ...
- 2mo agoAZNFDA Grants Accelerated Approval to a New Breast Cancer TreatmentFDA Press ReleasesThe U.S. Food and Drug Administration today expanded treatment options for adult patients with advanced breast cancer, reflecting the FDA’s commitment to advancing medical innovation and getting new treatments to patients who need them.FDA granted accelerated approval to Etcamah (camizestrant) in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for the treatment of adu ...
- 2mo agoIONSFDA Approves First Drug to Treat Alexander DiseaseFDA Press ReleasesThe U.S. Food and Drug Administration has approved Zanvastro (zilganersen) injection for the treatment of Alexander disease in pediatric and adult patients. Zanvastro is the first FDA-approved treatment for Alexander disease and the first therapy to directly target the protein buildup that drives the disease.“For patients with Alexander disease and their families, there have been no approved treat ...
- 2mo agoFDA Issues Emergency Use Authorization for Drugs to Prevent and Treat New World Screwworm in Dogs and CatsFDA Press ReleasesThe U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for Capstar (nitenpyram) tablets and revised the EUA for Nitenpyram Tablets, the generic version of Capstar, to authorize both products for the prevention and treatment of New World screwworm (NWS) infestations (myiasis) in dogs, puppies, cats, and kittens that weigh at least two pounds and are at least four we ...
- 2mo agoFDA Seeks Public Input to Advance Development of Botanical Drug ProductsFDA Press ReleasesAs part of the Trump Administration’s initiative to streamline regulatory pathways and foster medical innovation, the U.S. Food and Drug Administration today announced a request for information (RFI) to gather public input on opportunities to advance the development of botanical drug products.Botanical drug products are products that include or may be derived from plant materials, algae, macroscop ...
- 2mo agoFDA Approves First Drug of Its Kind for Polycythemia Vera, a Rare Blood DisorderFDA Press Releases
- 2mo agoFDA Issues Emergency Use Authorization for Generic Drug to Prevent New World Screwworm in CattleFDA Press ReleasesThe U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for Bimectin (ivermectin) injection for the prevention of New World screwworm (NWS) infestations (myiasis) in cattle when administered within 24 hours of birth, at the time of castration, or at the appearance of a wound – advancing the Trump Administration's goal of safeguarding American agriculture from NWS. B ...
- 2mo agoFDA Approves First Oral Drug Indicated to Treat Dermatomyositis in AdultsFDA Press ReleasesThe U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets for the treatment of dermatomyositis in adults. For decades, dermatomyositis patients have had limited treatment options to manage their symptoms. The approval of Lisraya offers patients an important new alternative by providing an effective oral treatment option.“For too long, patients with dermatomyositis have face ...
- 2mo agoFDA Approves First in Class Targeted Therapy for Metastatic Pancreatic CancerFDA Press Releases
- 2mo agoFDA Authorizes First Wearable Device That Continuously Monitors Both Ketone Levels and Blood SugarFDA Press ReleasesThe U.S. Food and Drug Administration today authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged 2 years and older living with diabetes. The Libre Duo 10 Day is the first wearable device in the U.S. that continuously monitors ketone levels, and the first in the world to continuously monitor both ketones and blood sugar (glucose) together in a single devi ...
- 2mo agoMSMRAREFDA Approves First Therapy for Patients aged 8 years and older with Glycogen Storage Disease Type IaFDA Press ReleasesThe U.S. Food and Drug Administration today issued an accelerated approval for Genglycos (pariglasgene brecaparvovec-opnr) to reduce daily cornstarch intake as an adjunct to nutritional management in adults and pediatric patients 8 years of age and older with glycogen storage disease type Ia (GSDIa), a rare, inherited genetic disorder caused by a deficiency of the enzyme glucose-6-phosphatase, whi ...
- 2mo agoFDA Authorizes First-Of-Its-Kind Robotic Blood Draw DeviceFDA Press Releases
- 2mo agoFDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical DevicesFDA Press Releases
- 3mo agoFDA Issues Emergency Use Authorization for Drug to Treat New World Screwworm in Dogs and PuppiesFDA Press Releases
- 3mo agoFDA Issues Emergency Use Authorization for Drug to Prevent New World Screwworm in Multiple Species, Including Sheep, Cattle, Goats, and SwineFDA Press ReleasesThe U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for CLiK Extra (dicyclanil topical suspension) wound spray for application on or around wounds for the prevention of New World screwworm (NWS) infestations (myiasis) in sheep, cattle, goats, swine, camelids (e.g., camels, llamas, alpacas), and the following captive and captured wildlife species: cervids (e.g., ...
- 3mo agoMSMREPLFDA Approves New Engineered Viral Immunotherapy for Patients with Treatment-Resistant Advanced MelanomaFDA Press ReleasesThe U.S. Food and Drug Administration today granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically modified oncolytic viral therapy for the treatment of advanced, refractory melanoma. Tudriqev is indicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a progr ...
- 3mo agoFDA Approves First Drug to Treat the Full Range of Narcolepsy Type 1 SymptomsFDA Press ReleasesThe U.S. Food and Drug Administration today approved Orzeyful (oveporexton) tablets for the treatment of narcolepsy type 1 in adults. Orzeyful is the first medicine approved for narcolepsy type 1 as a complete disorder — addressing the full range of symptoms that define the condition — and the first to work by directly targeting the loss of orexin signaling that causes the disease. “For too long, ...
- 3mo agoTFXFDA Licenses First-Ever Freeze-Dried Plasma Product in the U.S.FDA Press ReleasesThe U.S. Food and Drug Administration today licensed Ezplaz Freeze Dried Plasma (FDP), making it the first freeze-dried plasma product licensed for use in the United States. Ezplaz is intended for transfusion in adult patients who need plasma and for whom other plasma products are not available.“Patients experiencing life-threatening bleeding in combat zones, disasters, rural settings, or other au ...
- 3mo agoDXCMCMSFDA Announces First Participant Selected for TEMPO for Digital Health Devices PilotFDA Press ReleasesThe U.S. Food and Drug Administration today announced the first manufacturer selected for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot. The participating manufacturer intends to offer a device for use in providing care expected to be covered by the Centers for Medicare & Medicaid Services (CMS) Innovation Center’s ACCESS (Advancing Chronic Care with E ...
- 3mo agoFDA Takes Further Steps to Remove Outdated Authorizations for Color Additives in FoodFDA Press ReleasesThe U.S. Food and Drug Administration today announced two actions targeting petroleum-based color additives in food, continuing the agency’s broader efforts to Make America Healthy Again. The FDA is issuing a final order revoking the authorized use of Orange B as a color additive in food and is proposing to revoke the authorized use of Citrus Red No. 2 as a color additive in food.“The Trump Admini ...
- 3mo agoFDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High CholesterolFDA Press ReleasesThe U.S. Food and Drug Administration approved Lipfendra (enlicitide), the first oral inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9), as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, in adults with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH).PCSK9 inhibitors have prev ...
- 3mo agoROLFDA Issues Emergency Use Authorization for Drug for Short-Term Prevention of New World Screwworm in HorsesFDA Press ReleasesTo advance the Trump administration’s actions to safeguard American agriculture, the U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for Ivermectin Liquid for Horses (ivermectin oral solution) for the short-term prevention of New World screwworm (NWS) infestations (myiasis) in horses. The product is authorized for use when administered within 24 hours of birth o ...
- 4mo agoFDA Proposes Rule to Modernize Drug Manufacturing RegistrationFDA Press ReleasesThe U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would create a streamlined registration pathway for distributed manufacturing establishments that operate as a single establishment using a “hub-and-spoke” model. The proposed rule would also clarify registration requirements for certain foreign establishments that manufacture drugs, including active pharmaceuti ...
- 4mo agoROLLMSMFDA Approves First Gene Therapy for Young Children with Sickle Cell DiseaseFDA Press ReleasesThe U.S. Food and Drug Administration today issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged 2 years and older with either sickle cell disease (SCD) with recurrent vaso-occlusive crises (VOCs) or transfusion-dependent β thalassemia (TDT). This is the first gene therapy approved for patients aged 2 years and older with SCD. Casgevy has been previously approved ...
- 4mo agoFDA Approves New Treatment That Uses Donor Immune Cells to Prevent Serious Complications in Blood Cancer PatientsFDA Press ReleasesThe U.S. Food and Drug Administration today approved Tregzi, the first regulatory T (Treg) cell-based immunotherapy for improving chronic graft-versus-host disease (GVHD)-free survival in adult patients with blood cancers undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). It represents a novel approach to allogeneic hematopoietic stem cell transplantation in some adult pati ...
- 4mo agoAMRXREGNFDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug ManufacturingFDA Press ReleasesToday, the U.S. Food and Drug Administration announced the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative designed to boost American global competitiveness, strengthen domestic drug manufacturing, and improve the resilience of the U.S. drug supply chain.The FDA launched the PreCheck Pilot Program on February 1, 2026, in response to Executive Order 1 ...
- 4mo agoFDA Proposes Rule That Would Help Hold Foreign Tobacco Product Manufacturers Accountable, Protect Public HealthFDA Press ReleasesThe U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would help protect the public health of Americans, including youth, by strengthening the agency’s ability to efficiently identify illegal foreign tobacco products — including youth-appealing e-cigarettes — and conduct on-site inspections abroad. Domestic tobacco product manufacturers are currently required under ...
- 4mo agoFDA Approves First Single-Dose Generic Treatment for InfluenzaFDA Press ReleasesThe U.S. Food and Drug Administration today approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose treatment for acute uncomplicated influenza and prophylaxis in patients 5 years of age and older. Approved in time for the 2026–2027 flu season, this approval reflects the Trump Administration’s commitment to increasing the availability of generic drugs.“Today’s app ...
- 4mo agoAMPHFDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid OverdoseFDA Press ReleasesThe U.S. Food and Drug Administration (FDA) today approved another over-the-counter (OTC) intranasal naloxone product, Rextovy, a 4 milligram (mg) naloxone hydrochloride nasal spray for the emergency treatment of opioid overdose. Consumers may directly purchase this product without a prescription in places such as pharmacies, convenience stores, and online. This action aligns with President Trump’ ...