Drugs@FDA · Jul 23, 2026
FDA expands Furoscix (furosemide) approval
Efficacy supplement (new or revised indication). solution, subcutaneous. Sponsor: Scpharmaceuticals
Drugs & FDA · page 4
Drug approvals, label changes, and FDA drug news.
FDA Drugs · Jul 22, 2026
Health Fraud Scams
Learn how to spot health fraud and avoid it.
FDA Newsroom · Jul 22, 2026
FDA Takes Further Steps to Remove Outdated Authorizations for Color Additives in Food
The 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.
Drugs@FDA · Jul 22, 2026
FDA approves Jideytro (zidesamtinib)
Original new drug approval. tablet, oral. Sponsor: Nuvalent Inc
FDA Drugs · Jul 21, 2026
FDA Rare Disease Innovation Hub
FDA created the Rare Disease Innovation Hub (the Hub) to serve as a point of collaboration and connectivity between CBER and CDER with the goal of ultimately improving outcomes for patients.
FDA Drugs · Jul 21, 2026
Novel Drug Approvals at FDA
Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process.
FDA Drugs · Jul 21, 2026
List of Drug Master Files (DMFs)
The list is updated quarterly. Changes are made to the DMF activity status, DMF type, holder name, and subject.
FDA Drugs · Jul 20, 2026
Advancing Generic Drug Development: Leveraging Model-Integrated Evidence (MIE) in the Development & Approval of Generic Drugs - 08/27/2026
This half-day workshop includes a series of expert-lead presentations and audience Q&A sessions focused on the latest advancements and regulatory considerations in the evolving field of Model-Integrated Evidence (MIE)-supported generic drug development and approval.
FDA Drugs · Jul 20, 2026
Written Requests Issued
Updated list of approved active moieties to which FDA has issued a Written Request for pediatric studies
FDA Drugs · Jul 20, 2026
The Center for Research on Complex Generics
FDA awards a 5-year grant to the University of Maryland and the University of Michigan to establish a Center for Research on Complex Generics (CRCG).
Drugs@FDA · Jul 19, 2026
FDA approves Air (air)
Original new drug approval. gas, inhalation. Sponsor: Noble Gas Solutions Inc.
FDA Drugs · Jul 17, 2026
Innovative Science and Technology Approaches for New Drugs (ISTAND) Program Submission Process
The 21st Century Cures Act formally established a multi-step process for Drug Development Tools (DDT) qualification. Qualification of a DDT is for a specific context of use (COU), and the qualified DDT may be used for the COU by any person in drug or biologics development.
FDA Newsroom · Jul 17, 2026
FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol
The 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 hypercholesterolemi
FDA Drugs · Jul 16, 2026
Pediatric Exclusivity Granted
Approved active drugs with sponsors to which FDA has granted exclusivity for pediatric studies under Section 505A of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
FDA Drugs · Jul 16, 2026
How to Spot Health Fraud
How to Spot Health Fraud
FDA Drugs · Jul 16, 2026
CDER Manual of Policies & Procedures | MAPP
CDER's Manual of Policies and Procedures (MAPPs) are federal directives and documentation of internal policies and procedures.
Drugs@FDA · Jul 16, 2026
FDA expands Ilumya (tildrakizumab-asmn) approval
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Sun Pharma Global
Drugs@FDA · Jul 16, 2026
FDA expands Fabhalta (iptacopan hydrochloride) approval
Efficacy supplement (new or revised indication). capsule, oral. Sponsor: Novartis
Drugs@FDA · Jul 16, 2026
FDA expands Rezzayo (rezafungin acetate) approval
Efficacy supplement (new or revised indication). powder, intravenous. Sponsor: Mundipharma
FDA Drugs · Jul 16, 2026
FDA Approves First Oral Therapy that Inhibits Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) to Lower Bad Cholesterol in Adults with High Cholesterol
FDA has approved Lipfendra (enlicitide) as a treatment to be used with diet and exercise, to reduce low-density lipoprotein cholesterol (LDL-C) in adults with high cholesterol or who have an inherited type of high cholesterol called heterozygous familial hypercholesterolemia (HeFH).
MedCity News · Jul 15, 2026
Celcuity’s First-in-Class Drug Gets FDA Approval in Most Common Type of Breast Cancer
Celcuity drug Revtorpyk is now approved for advanced cases of the most common type of breast cancer that do not harbor a certain mutation. The intravenously infused medicine is first in a new drug class that addresses a pathway associated with many cancers. The post Celcuity’s First-in-Class Drug Gets FDA Approval in Most Common Type of Breast Cancer appeared first on MedCity News .
FDA Drugs · Jul 15, 2026
Natural Disaster Preparedness and Response | Drugs
Stay informed on FDA's guidance for drugs used in natural disaster preparedness and response. Learn about emergency drug supplies, FDA-approved treatments, and safety measures for public health during disasters like hurricanes, floods, and more.
FDA Drugs · Jul 15, 2026
Safe Drug Use After a Natural Disaster
Information on the use of medicines that may be affected by fire, flooding or unsafe water, and on the use of temperature-sensitive drugs when refrigeration is temporarily unavailable.
FDA Newsroom · Jul 15, 2026
FDA Issues Emergency Use Authorization for Drug for Short-Term Prevention of New World Screwworm in Horses
The FDA 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 when administered within 24 hours of birth or at the time of initial wound care.