Approvals and regulatory news
FDA and Health Canada approvals, rejections and rule changes. Sources on every story.
FDA Faults Baxter Oversight, Cites 4 Failings at Illinois Drug Plant
An FDA warning letter says Baxter's management oversight is inadequate after inspectors found contamination and sterility gaps at its Round Lake plant.
FDA Approves GSK's Hibsago for Chronic Hepatitis B
The FDA approved GSK's bepirovirsen, sold as Hibsago, for some adults with chronic hepatitis B. It is the first antisense drug the agency has approved for the disease.
FDA Approves Genentech's Enspryng for Thyroid Eye Disease
The FDA approved Enspryng as the first at-home injection for thyroid eye disease, though one of its two phase 3 trials missed its main goal.
China Moves to Ban Foreign Buyouts of Key Biotech Platforms
China proposed barring foreign buyers from its cell and gene therapy and siRNA platforms. Out-licensing deals are excluded from the ban.
CraniUS Therapeutics Secures Second FDA Clearance in Six Weeks
CraniUS Therapeutics achieves rapid regulatory success with FDA 510(k) clearance and patent protection for NeuroPASS™ 3, marking advancement in targeted brain therapy.
FDA Approves First Heart Valve Designed to Grow with Children
Groundbreaking FDA approval of pediatric heart valve that expands with patient growth eliminates multiple surgeries, marking major advance in pediatric cardiology.
FDA Targets Hangover Supplement Makers in Marketing Claims Crackdown
FDA issues warning letters to seven hangover supplement companies for illegal therapeutic claims, signaling heightened enforcement scrutiny beyond contamination issues.
FDA Issues Warning Letter Over Serious Manufacturing Violations
FDA warns American Pharma Manufacturing after March 2026 inspection revealed critical quality control failures and Current Good Manufacturing Practice violations.
FDA Approves First Once-Weekly Insulin for Type 2 Diabetes
FDA grants approval to Onswik (insulin efsitora alfa-gobe), the first once-weekly insulin therapy for Type 2 Diabetes, marking a potential paradigm shift in treatment adherence.
GLP-1 Powder Supplements Spark Safety Concerns Amid Regulatory Gap
Health experts warn consumers about unregulated GLP-1 powder supplements flooding the market as demand surges during branded drug shortages, raising serious safety questions.
FDA Launches Expedited IND Pilot to Accelerate Clinical Trials
The FDA's new Expedited IND Pilot Program pairs sponsors with research institutions to reduce early-phase trial delays, potentially shortening drug development timelines.
FDA Issues Emergency Guidance on Hospital Ibuprofen Compounding
FDA allows hospitals to compound ibuprofen suspension addressing pediatric fever treatment and swallowing difficulties amid supply shortages—a significant shift in policy.
New Bill Aims to Overhaul FDA's Dietary Supplement Drug Preclusion Rules
Rep. Harshbarger introduces legislation to modernize DSHEA's drug preclusion clause, potentially unlocking innovation by capping indefinite exclusions and requiring science-based reviews.
FDA Targets Seven Companies Over Illegal Hangover Cure Claims
FDA issues coordinated warning letters to dietary supplement marketers making illegal disease treatment claims for hangover products, signaling regulatory crackdown.
FDA Opens Public Comment Period on Botanical Drug Development
FDA seeks industry input on botanical drug development after expert roundtables, signaling potential expansion of regulatory pathways for plant-based therapeutics.
FDA Proposes Salt Substitute Standards Amid Heart Health Push
FDA's proposed rule on salt substitutes in food products signals major shift in sodium reduction strategy, with implications for hypertension treatments and supplement markets.
International Harmonization of Supplement Regulations Gains Momentum
Global regulatory bodies accelerate efforts to align supplement standards, with new framework proposals targeting cross-border commerce and consumer safety.
California Proposes Mandatory Heavy Metal Testing for Protein Brands
Senate Bill 1033 would establish first-in-nation mandatory testing and disclosure requirements for heavy metals in protein supplements amid contamination concerns.
US Proposes Up to 200% Tariffs on Indian Generic Drug Imports
Proposed escalating tariffs on generic pharmaceuticals from India could fundamentally reshape US drug pricing and supply chains, threatening access to affordable medications.
Erasca Wins FDA Fast Track for ERAS-0015 in Pancreatic Cancer
FDA grants fast track designation to Erasca's ERAS-0015 for pancreatic cancer treatment, signaling regulatory momentum for precision oncology in difficult-to-treat malignancies.