FDA Drugs · Jul 6, 2026
Search for Regulatory References | Drugs
Find information on drug development, applications, submissions, manufacturing & quality, safety, labeling and more
Drugs & FDA · page 8
Drug approvals, label changes, and FDA drug news.
FDA Drugs · Jul 6, 2026
FDA authorizes Gohibic (vilobelimab) injection for the treatment of COVID-19
FDA authorizes Gohibic (vilobelimab) injection
FDA Drugs · Jul 6, 2026
Upcoming EL-PFDD Meetings
Upcoming EL-PFDD Meetings
FDA Drugs · Jul 6, 2026
Condition-Specific Meeting Reports and Other Information Related to Patients' Experience
This webpage provides links to certain publicly available external reports and resources relating to patient experience data. The patient community, patient advocates, researchers, drug developers, and federal agencies may find these materials useful.
FDA Drugs · Jul 2, 2026
FDA Alerts Health Care Providers to Cases of Neurologic Complications from General Anesthesia Linked to Genetic Variant in Patients of Maternal Venezuelan Ancestry
The U.S. Food and Drug Administration (FDA) is investigating the safety of sevoflurane and other general anesthetics based on published scientific reports of unexpected catastrophic outcomes, including severe neurologic adverse outcomes and death, occurring in adult and pediatric patients.
FDA Drugs · Jul 2, 2026
Drug Alerts and Statements
See updates from CDER on fast-moving issues and learn about CDER's work to enhance public health
FDA Drugs · Jul 2, 2026
FDA Listing of Authorized Generics
FDA Listing of Authorized Generics
FDA Drugs · Jul 2, 2026
Patient Education
Generic medications are just as safe and effective as their brand-name counterparts, and often cost less. To help educate patients about FDA’s rigorous review process, the economics of pricing, and related issues, FDA offers a range of educational materials, including videos, graphics, fact sheets,.
FDA Drugs · Jul 2, 2026
Preventing Accidental Apoquel Chewable Overdoses
The FDA has received an increasing number of reports of pets accidentally overdosing on Apoquel Chewable (oclacitinib chewable tablets), a flavored chewable medicine approved only for dogs.
BMJ Open · Jul 2, 2026
Workforce shortages and supported access to medical care for hospital employees: a scoping review
Objectives This scoping review synthesises peer-reviewed and grey literature on supported access to medical care for hospital employees with existing physical health complaints to understand how it may reduce sickness absenteeism by promoting sustainable employability and to identify gaps and opportunities to inform the design and implementation of organisational supported care frameworks. Design We conducted this scoping review following the Arksey and O’Malley framework and Levac et al ’s methodological recommendations, reported in accordance with Preferred Reporting Items for Systematic…
MedCity News · Jul 2, 2026
FDA Approves First Neurostimulation Device for PTSD
Neurovalens’ Modius Spero has become the first FDA-approved neuromodulation device for treating PTSD symptoms. Veterans are set to gain access through the VA this summer. The post FDA Approves First Neurostimulation Device for PTSD appeared first on MedCity News .
FDA Drugs · Jul 1, 2026
Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products
The HHS Secretary determined that circumstances no longer exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic. The authorizing emergency use of drug and biological products for COVID-19 will be terminated.
FDA Newsroom · Jul 1, 2026
FDA Approves First Gene Therapy for Young Children with Sickle Cell Disease
The 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).
FDA Drugs · Jul 1, 2026
MAGNUM Brand products may be harmful due to hidden drug ingredients
The Food and Drug Administration continues advising consumers not to purchase or use MAGNUM brand products sold for sexual enhancement across various websites and retail stores. FDA laboratory analysis has confirmed that MAGNUM brand products sold in various dosage forms including capsules and honey
FDA Drugs · Jul 1, 2026
BlackBerry QNX Cybersecurity Vulnerabilities May Affect Drug Manufacturing Equipment
To protect public health and safety, the FDA provides guidance to drug manufacturers on staying cyber secure.
FDA Drugs · Jul 1, 2026
CDER Quality Management Maturity
FDA has proposed the development of a rating system that will help incentivize drug manufacturers to achieve Quality Mangement Maturity at their facilities.
FDA Drugs · Jul 1, 2026
Submitting Next-Generation Sequencing Data to the Division of Antiviral Products
Electronic Submissions and Clinical/Antimicrobial.
Drugs@FDA · Jul 1, 2026
FDA expands Kisqali Femara Co-Pack (Copackaged) (letrozole, ribociclib succinate) approval
Efficacy supplement (new or revised indication). tablet, oral. Sponsor: Novartis
Drugs@FDA · Jul 1, 2026
FDA expands Kisqali (ribociclib succinate) approval
Efficacy supplement (new or revised indication). tablet, oral. Sponsor: Novartis
FDA Drugs · Jun 30, 2026
FDA approves allogeneic regulatory T cell-based immunotherapy with HSPC and T cells-vldq for use in matched donor hematopoietic stem cell transplantation for adults with hematologic malignancies
FDA approves allogeneic regulatory T cell-based immunotherapy with HSPC and T cells-vldq for use in matched donor hematopoietic stem cell transplantation for adults with hematologic malignancies
FDA Newsroom · Jun 30, 2026
FDA Approves New Treatment That Uses Donor Immune Cells to Prevent Serious Complications in Blood Cancer Patients
The 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).
FDA Drugs · Jun 30, 2026
January - March 2026 | New Safety Information or Potential Signals of Serious Risks Identified by the FDA Adverse Event Monitoring System (AEMS)
January - March 2026 | New Safety Information or Potential Signals of Serious Risks Identified by the FDA Adverse Event Monitoring System (AEMS)
FDA Drugs · Jun 30, 2026
Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2012 – present
The following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA.
FDA Drugs · Jun 30, 2026
Qualified Clinical Outcome Assessments (COA)
The table below lists qualified Clinical Outcome Assessments (COA). The tables include legacy projects (those submitted prior to passage of the 21st Century Cures Act), as well as those submitted as part of the newer section 507 process (referring to section 507 of the Federal Food, Drug and Cosmeti