FDA Grants Accelerated Approval to a New Breast Cancer Treatment
http://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-new-breast-cancer-treatment
http://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-new-breast-cancer-treatment
U.S. Food and Drug Administration
FDA Grants Accelerated Approval to a New Breast Cancer Treatment
The 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 Takes Steps to Maintain Newborn Access to Life-Saving Starter Nutrition Products
http://www.fda.gov/news-events/press-announcements/fda-takes-steps-maintain-newborn-access-life-saving-starter-nutrition-products
http://www.fda.gov/news-events/press-announcements/fda-takes-steps-maintain-newborn-access-life-saving-starter-nutrition-products
U.S. Food and Drug Administration
FDA Takes Steps to Maintain Newborn Access to Life-Saving Starter Nutrition Products
The 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…
FDA Launches Expedited IND Pilot, Begins Accepting Applications
http://www.fda.gov/news-events/press-announcements/fda-launches-expedited-ind-pilot-begins-accepting-applications
http://www.fda.gov/news-events/press-announcements/fda-launches-expedited-ind-pilot-begins-accepting-applications
U.S. Food and Drug Administration
FDA Launches Expedited IND Pilot, Begins Accepting Applications
The U.S. Food and Drug Administration today announced the final design of the Expedited Investigational New Drug (IND) Pilot.
FDA Approves First Gene Therapy for Pediatric Patients with Sanfilippo Syndrome Type A
http://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-pediatric-patients-sanfilippo-syndrome-type
http://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-pediatric-patients-sanfilippo-syndrome-type
U.S. Food and Drug Administration
FDA Approves First Gene Therapy for Pediatric Patients with Sanfilippo Syndrome Type A
The 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.
FDA Updates Regulations to Advance Innovative Alternatives to Animal Testing
http://www.fda.gov/news-events/press-announcements/fda-updates-regulations-advance-innovative-alternatives-animal-testing
http://www.fda.gov/news-events/press-announcements/fda-updates-regulations-advance-innovative-alternatives-animal-testing
U.S. Food and Drug Administration
FDA Updates Regulations to Advance Innovative Alternatives to Animal Testing
The FDA 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.
Federal Court Enters Consent Decree Against Gold Star Distribution, Inc. Following Persistent Insanitary Warehouse Conditions
http://www.fda.gov/news-events/press-announcements/federal-court-enters-consent-decree-against-gold-star-distribution-inc-following-persistent
http://www.fda.gov/news-events/press-announcements/federal-court-enters-consent-decree-against-gold-star-distribution-inc-following-persistent
U.S. Food and Drug Administration
Federal Court Enters Consent Decree Against Gold Star Distribution, Inc. Following Persistent Insanitary Warehouse Conditions
A 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…
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FDA intends to evaluate changes to the PMTA regulatory framework
http://www.fda.gov/news-events/press-announcements/fda-intends-evaluate-changes-pmta-regulatory-framework
http://www.fda.gov/news-events/press-announcements/fda-intends-evaluate-changes-pmta-regulatory-framework
U.S. Food and Drug Administration
FDA intends to evaluate changes to the PMTA regulatory framework
FDA 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…
FDA Approves First Treatment for MCT8 Deficiency
http://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-mct8-deficiency
http://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-mct8-deficiency
U.S. Food and Drug Administration
FDA Approves First Treatment for MCT8 Deficiency
The U.S. Food and Drug Administration today approved Emcitate (tiratricol) tablets for oral suspension to treat peripheral thyrotoxicosis (excess thyroid hormone levels in the blood that causes symptoms, such as rapid heart rate, increased blood pressure…
FDA Investigation Leads to Charges Against Two Indian Nationals Involved in Transnational Counterfeit Drug Distribution Scheme
http://www.fda.gov/news-events/press-announcements/fda-investigation-leads-charges-against-two-indian-nationals-involved-transnational-counterfeit-drug
http://www.fda.gov/news-events/press-announcements/fda-investigation-leads-charges-against-two-indian-nationals-involved-transnational-counterfeit-drug
U.S. Food and Drug Administration
FDA Investigation Leads to Charges Against Two Indian Nationals Involved in Transnational Counterfeit Drug Distribution Scheme
The 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.
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FDA Launches Nationwide Effort to Expand Scientific Expertise and Consumer Voices to Advisory Committees
http://www.fda.gov/news-events/press-announcements/fda-launches-nationwide-effort-expand-scientific-expertise-and-consumer-voices-advisory-committees
http://www.fda.gov/news-events/press-announcements/fda-launches-nationwide-effort-expand-scientific-expertise-and-consumer-voices-advisory-committees
FDA Approves First Heart Valve Designed to Grow with Children
http://www.fda.gov/news-events/press-announcements/fda-approves-first-heart-valve-designed-grow-children
http://www.fda.gov/news-events/press-announcements/fda-approves-first-heart-valve-designed-grow-children
U.S. Food and Drug Administration
FDA Approves First Heart Valve Designed to Grow with Children
The 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.
FDA Seeks Public Input to Support Ibogaine Research
http://www.fda.gov/news-events/press-announcements/fda-seeks-public-input-support-ibogaine-research
http://www.fda.gov/news-events/press-announcements/fda-seeks-public-input-support-ibogaine-research
U.S. Food and Drug Administration
FDA Seeks Public Input to Support Ibogaine Research
The U.S. Food and Drug Administration today announced a request for information (RFI) describing approaches the agency is considering for the design of early-phase clinical trials of ibogaine drug products and seeking public input on those approaches.
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FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer
http://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-certain-people-bcg-unresponsive-bladder-cancer
http://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-certain-people-bcg-unresponsive-bladder-cancer
U.S. Food and Drug Administration
FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer
FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer
FDA Launches the Rare Disease Framework Initiative to Develop a Holistic, Fit-For-Purpose Framework for Rare Disease Drug Development
http://www.fda.gov/news-events/press-announcements/fda-launches-rare-disease-framework-initiative-develop-holistic-fit-purpose-framework-rare-disease
http://www.fda.gov/news-events/press-announcements/fda-launches-rare-disease-framework-initiative-develop-holistic-fit-purpose-framework-rare-disease
U.S. Food and Drug Administration
FDA Launches the Rare Disease Framework Initiative to Develop a Holistic, Fit-For-Purpose Framework for Rare Disease Drug Development
The 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.
New WHO technical package to help countries improve health data for COVID-19 response and beyond
https://www.who.int/news/item/27-08-2020-new-who-technical-package-health-data-for-covid-19-response
https://www.who.int/news/item/27-08-2020-new-who-technical-package-health-data-for-covid-19-response
World Health Organization
New WHO technical package to help countries improve health data for COVID-19 response and beyond
Today, as part of its commitment to strengthening health information systems and improving health[1], especially in the context of the COVID-19 pandemic, WHO announced a new approach to improving access to life-saving data: the SCORE for Health Data Technical…
FDA Approves Immunotherapy That May Allow Certain Patients with Rectal Cancer to Avoid Chemotherapy, Radiation and Surgery
http://www.fda.gov/news-events/press-announcements/fda-approves-immunotherapy-may-allow-certain-patients-rectal-cancer-avoid-chemotherapy-radiation-and
http://www.fda.gov/news-events/press-announcements/fda-approves-immunotherapy-may-allow-certain-patients-rectal-cancer-avoid-chemotherapy-radiation-and
U.S. Food and Drug Administration
FDA Approves Immunotherapy That May Allow Certain Patients with Rectal Cancer to Avoid Chemotherapy, Radiation and Surgery
The 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…
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FDA Issues Final Guidance on Prescription Drug Apps and Software
http://www.fda.gov/news-events/press-announcements/fda-issues-final-guidance-prescription-drug-apps-and-software
http://www.fda.gov/news-events/press-announcements/fda-issues-final-guidance-prescription-drug-apps-and-software
U.S. Food and Drug Administration
FDA Issues Final Guidance on Prescription Drug Apps and Software
The 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.
FDA Approves Once-Weekly Generic Hormone Therapy Patch for Women
http://www.fda.gov/news-events/press-announcements/fda-approves-once-weekly-generic-hormone-therapy-patch-women
http://www.fda.gov/news-events/press-announcements/fda-approves-once-weekly-generic-hormone-therapy-patch-women
U.S. Food and Drug Administration
FDA Approves Once-Weekly Generic Hormone Therapy Patch for Women
Today, 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.
FDA Approves First-of-Its-Kind Chronic Hepatitis B Treatment
http://www.fda.gov/news-events/press-announcements/fda-approves-first-its-kind-chronic-hepatitis-b-treatment
http://www.fda.gov/news-events/press-announcements/fda-approves-first-its-kind-chronic-hepatitis-b-treatment
U.S. Food and Drug Administration
FDA Approves First-of-Its-Kind Chronic Hepatitis B Treatment
FDA today approved Hibsago (bepirovirsen) injection, in combination with existing antiviral therapy, to treat chronic hepatitis B virus (HBV) infection in certain adults without cirrhosis.