Regulatory Updates
FDA, EMA, TGA and global regulatory developments
Regulatory Updates
Aug 30, 2026•1 min read
MHRA Safety Roundup – Latest Advice for Medicines and Devices
A brief summary of the MHRA’s latest safety advice for medicines and medical device users.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Recall Issued Due to Lack of Assurance of Sterility
The FDA has initiated a recall because the product lacks assurance of sterility, raising safety concerns.
Regulatory Updates
Aug 30, 2026•1 min read
Claudin18.2‑Targeted CAR‑T Therapy Achieves First Global Approval for Solid Tumor
Claudin18.2‑targeted CAR‑T therapy is the first CAR‑T to receive global approval for a solid tumor.
Regulatory Updates
Aug 30, 2026•1 min read
MHRA Announces Ninth Annual MedSafety Week, 4‑10 November 2024
The MHRA's ninth MedSafety Week runs 4‑10 November 2024, encouraging public reporting of medication safety issues.
Regulatory Updates
Aug 30, 2026•1 min read
MHRA March 2024 Letters and Medicine Recalls Summary
A brief overview of letters and notifications sent to UK healthcare professionals about medicines and medical devices in March 2024.
Regulatory Updates
Aug 30, 2026•1 min read
FDA halts Sobi's gout drug challenger to Amgen's Krystexxa
The FDA has put Sobi's planned gout medication on hold, delaying its challenge to Amgen's Krystexxa.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA084306 for MYDRIACYL (Tropicamide 1% Ophthalmic Solution)
The FDA has approved ANDA084306 for MYDRIACYL, a 1% tropicamide ophthalmic solution marketed by Alcon Laboratories.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Grants Approval for Teva’s Chlordiazepoxide Hydrochloride (ANDA 084768)
The FDA has approved Teva Pharmaceuticals’ oral capsule generic of chlordiazepoxide hydrochloride under ANDA 084768, with multiple supplemental manufacturing and labeling approvals.
Regulatory Updates
Aug 30, 2026•1 min read
GE Healthcare Alerts: CARESCAPE Central Station May Delay Monitoring After Restart
GE Healthcare reports that the CARESCAPE Central Station (CSCS) v3.0.x may not resume patient monitoring for at least three minutes after a system restart.
Regulatory Updates
Aug 30, 2026•1 min read
GE Healthcare CARESCAPE Central Station v3.0.x May Delay Monitoring After Restart
GE Healthcare reports that its CARESCAPE Central Station v3.0.x may fail to resume patient monitoring for at least three minutes after a system restart.
Regulatory Updates
Aug 30, 2026•1 min read
Korean Lawmakers Propose Renaming "High-Level" Hospitals to "Severe" Hospitals
A medical law amendment to replace the term "상급종합병원" with "중증종합병원" has been introduced to clarify hospital functions and ease large‑hospital concentration.
Regulatory Updates
Aug 30, 2026•2 min read
WHO Nations Agree to Continue Drafting Global Pandemic Agreement Ahead of WHA
Governments met at WHO headquarters to resume hybrid discussions on a proposed pandemic agreement, focusing on pathogen sharing, One Health and financing before the 77th World Health Assembly.