FDA Drugs · Jul 9, 2026
eCTD Submission Standards for eCTD v3.2.2 and Regional M1
eCTD Submission Standards
Drugs & FDA · page 7
Drug approvals, label changes, and FDA drug news.
FDA Drugs · Jul 9, 2026
eCTD Submission Standards for eCTD v4.0 and Regional M1
A listing of the Implementation Guides, Specifications, and Documentation that support the FDA implementation for eCTD v4.0
FDA Drugs · Jul 9, 2026
The FDA at 120: A Long, Distinguished History Protecting Americans
Since 1906 Americans have relied on, and benefited from, the FDA’s oversight of our food, medical products, veterinary products, cosmetics, and so much more.
FDA Drugs · Jul 9, 2026
Preparing Patient and Caregiver Participants for an FDA Patient-Led Listening Session and Suggested Topics
Learn about topics that are outside of the scope of FDA’s work and suggested topics for FDA-Patient-Led Listening Sessions.
FDA Drugs · Jul 9, 2026
Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D)
As part of the Accelerating Rare disease Cures (ARC) Program, CDER’s Rare Diseases Team inaugurated the Learning and Education to Advance and Empower Rare Disease Drug Developers (LEADER 3D) initiative. Learn more.
MedTech Dive · Jul 9, 2026
J&J wins FDA approval for dual-energy ablation catheter
Johnson & Johnson expects U.S. physicians to perform the first procedures with the device this summer as it starts a phased commercial rollout.
Drugs@FDA · Jul 9, 2026
FDA approves Sodium Bicarbonate (sodium bicarbonate)
Original new drug approval. solution, intravenous. Sponsor: Amneal
Drugs@FDA · Jul 9, 2026
FDA approves Sarclisa Escena (isatuximab-irfc)
Original biologic license approval. vial, single-dose. Sponsor: Sanofi-Aventis U.S. Llc
MedCity News · Jul 8, 2026
Vera Therapeutics’ First-in-Class Kidney Disease Drug Lands Speedy FDA Approval
FDA approval of Vera Therapeutics’ Trutakna makes it first in a new class of medicines designed to block two targets to treat immunoglobulin A nephropathy, an autoimmune disease that can progress to end-stage renal failure. Competition looms from Vertex Pharmaceuticals, on track to receive a November regulatory decision for a drug designed to block the same two proteins. The post Vera Therapeutics’ First-in-Class Kidney Disease Drug Lands Speedy FDA Approval appeared first on MedCity News .
FDA Drugs · Jul 8, 2026
National Drug Code Format
FDA’s final rule, Revising the National Drug Code Format and Drug Label Barcode Requirements, adopts a uniform, 12-digit format for the national drug code (NDC).
FDA Drugs · Jul 8, 2026
CDER Streamlined Nonclinical Studies and Acceptable New Approach Methodologies (NAMs)
It has become increasingly clear that new approach methodologies (NAMs)—when combined with knowledge of the pathway, results of pharmacology studies, and other relevant data—may offer ways to reduce animal testing.
FDA Drugs · Jul 7, 2026
Medical Products for Rare Diseases and Conditions
The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons
FDA Drugs · Jul 7, 2026
FDA Approves New Treatment to Reduce Proteinuria in Adults with Primary Immunoglobulin A Nephropathy
The U.S. Food and Drug Administration (FDA) has approved Trutakna (atacicept-vymj) to reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progression.
FDA Drugs · Jul 7, 2026
MIDD Paired Meeting Program Frequently Asked Questions
MIDD Pilot Program Frequently Asked Questions (FAQs)
FDA Drugs · Jul 7, 2026
Model-Informed Drug Development Paired Meeting Program
FDA is conducting a MIDD Pilot Program to facilitate the development and application of exposure-based, biological, and statistical models derived from preclinical and clinical data sources, referred to as MIDD approaches.
Drugs@FDA · Jul 7, 2026
FDA approves Trutakna (atacicept-vymj)
Original biologic license approval. injectable, subcutaneous. Sponsor: Vera Therapeutics Inc.
Drugs@FDA · Jul 7, 2026
FDA expands Ryaltris (mometasone furoate, olopatadine hydrochloride) approval
Efficacy supplement (new or revised indication). spray, metered, nasal. Sponsor: Glenmark Speclt
FDA Drugs · Jul 6, 2026
Innovation to Respond to COVID-19
Learn about FDA’s innovative approaches to respond to COVID-19 as quickly and safely as possible.
FDA Drugs · Jul 6, 2026
Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19
Today, the FDA issued an emergency use authorization for the drug baricitinib, in combination with remdesivir, for the treatment of COVID-19 in hospitalized adults and pediatric patients 2+ years requiring supplemental oxygen, invasive mechanical ventilation, or ECMO.
FDA Drugs · Jul 6, 2026
COVID-19 Update: FDA’s Ongoing Commitment to Transparency for COVID-19 EUAs
FDA is committed to transparency around the EUA process
FDA Drugs · Jul 6, 2026
FDA Approves First Treatment for COVID-19
FDA approved the antiviral drug Veklury (remdesivir) for adults and pediatric patients 12 years of age and older for the treatment of COVID-19 requiring hospitalization. Veklury is the first treatment for COVID-19 to receive FDA approval.
FDA Drugs · Jul 6, 2026
Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment
FDA has issued emergency use authorization for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.
FDA Drugs · Jul 6, 2026
Some Homeopathic Products May Put You at Risk
Homeopathic products are marketed without FDA review and may not meet modern standards for safety, effectiveness, quality and labeling. Learn more.
FDA Drugs · Jul 6, 2026
FDA’s approval of Veklury (remdesivir) for the treatment of COVID-19—the science of safety and effectiveness
FDA recognizes that patients affected by coronavirus 2019 (COVID-19) are in great need of medicines to treat this disease. To help meet this need, the agency is helping to speed the development of promising therapies through its Coronavirus Treatment Acceleration Program (CTAP).