FDA Drugs · Jul 24, 2026
Novel Drug Approvals for 2026
FDA Novel Drug Therapy Approvals for 2026
Drugs & FDA · page 3
Drug approvals, label changes, and FDA drug news.
FDA Drugs · Jul 24, 2026
FDA Approves First Nonprescription Fixed-Dose Combination of Acetaminophen and Naproxen Sodium for 12-Hour Pain Relief
On July 24, FDA approved Tylenol with Naproxen (acetaminophen 325 mg/naproxen sodium 110 mg tablets), the first fixed-dose combination product to pair acetaminophen with naproxen sodium in a single combination tablet for up to 12 hours of pain relief.
FDA Drugs · Jul 24, 2026
FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury
FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury
FDA Drugs · Jul 24, 2026
M15 General Principles for Model-Informed Drug Development
M15 General Principles for Model-Informed Drug Development
FDA Drugs · Jul 24, 2026
General Considerations for the Use of New Approach Methodologies in Drug Development
This draft guidance provides drug developers with a validation framework and general recommendations for using new approach methodologies (NAMs) in drug development.
FDA Drugs · Jul 24, 2026
Monoclonal Antibodies: Streamlined Nonclinical Safety Studies
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Monoclonal Antibodies: Streamlined Nonclinical Safety Studies.”
FDA Drugs · Jul 24, 2026
Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products
Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products
FDA Drugs · Jul 24, 2026
Critical Path Innovation Meetings (CPIM)
Critical Path Innovation Meetings (CPIM)
FDA Drugs · Jul 24, 2026
Innovative Science and Technology Approaches for New Drugs (ISTAND) Program
The Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program is designed to expand DDT types by encouraging development of DDTs that are out of scope for existing DDT qualification programs but may still be beneficial for drug development.
FDA Drugs · Jul 24, 2026
New Approach Methodologies (NAMs)
The FDA is leading a transformative shift in drug safety evaluation—reducing, replacing or refining animal testing with advanced, human-relevant methods that better predict how medicines work in people.
Drugs@FDA · Jul 24, 2026
FDA approves Symtriyo (centanafadine hydrochloride)
Original new drug approval. capsule, extended release. Sponsor: Otsuka Pharmaceutical Co Ltd
Drugs@FDA · Jul 24, 2026
FDA expands Idkit:Hp (citric acid, urea c-13) approval
Efficacy supplement (new or revised indication). for solution, tablet, for solution, oral. Sponsor: Meridian Bioscience
Drugs@FDA · Jul 24, 2026
FDA approves Tylenol With Naproxen (naproxen sodium, acetaminophen)
Original new drug approval. tablet. Sponsor: Kenvue Brands Llc
Drugs@FDA · Jul 24, 2026
FDA expands Xtandi (enzalutamide) approval
Efficacy supplement (new or revised indication). tablet, oral. Sponsor: Astellas
Drugs@FDA · Jul 24, 2026
FDA expands Xtandi (enzalutamide) approval
Efficacy supplement (new or revised indication). capsule, oral. Sponsor: Astellas
Drugs@FDA · Jul 24, 2026
FDA approves Lytenava (bevacizumab-vikg)
Original biologic license approval. vial, single-dose. Sponsor: Outlook Therapeutics, Inc.
Drugs@FDA · Jul 24, 2026
FDA approves Garzulys (insulin aspart-fsan)
Original biologic license approval. vial, multidose. Sponsor: Emerge Bioscience Pte. Ltd.
FDA Drugs · Jul 23, 2026
Kangaroo Intense Venus 3000 may be harmful due to hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use Kangaroo Intense Venus 3000, a product promoted for sexual enhancement on various websites, including https://usroyalhoney.com, and possibly in some retail stores.
FDA Drugs · Jul 23, 2026
FDA/Center for Research on Complex Generics (CRCG) Workshop on Navigating the GLP-1 Generic Drug Pathway - 09/23/2026
This 2-day workshop will address some of the key product development and regulatory assessment considerations for generic glucagon-like peptide-1 (GLP-1) agonist products.
FDA Drugs · Jul 23, 2026
Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program
Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program (CDRP)
FDA Drugs · Jul 23, 2026
Inactive Ingredients Database Download
Data updated through July 2026
FDA Drugs · Jul 23, 2026
Quarterly Inactive Ingredient Database (IID) Change Log
Quarterly IID Change Log displays changes made since the previous quarterly IID publication.
Drugs@FDA · Jul 23, 2026
FDA expands Macrilen (macimorelin acetate) approval
Efficacy supplement (new or revised indication). for solution, oral. Sponsor: Aeterna Zentaris
Drugs@FDA · Jul 23, 2026
FDA expands Furoscix (furosemide) approval
Efficacy supplement (new or revised indication). solution, subcutaneous. Sponsor: Scpharmaceuticals