On November 14, 2025, Swissmedic officially announced the first authorization of DATROWAY®, marking an important step…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
Swissmedic Grants First Authorization for Pylclari®: Key Updates for Regulatory Teams
On November 14, 2025, Swissmedic officially announced the first regulatory authorization of Pylclari®, marking an important…
Swissmedic Announces Enhanced Use of Enhertu® for Extended Therapeutic Indications
Swissmedic, Switzerland’s regulatory authority for therapeutic products, has announced the authorization of an extended therapeutic indication…
FDA Announces Appointment of Richard Pazdur as New CDER Director
The U.S. Food and Drug Administration (FDA) has confirmed that Dr. Richard Pazdur, a seasoned expert…
Urgent Medicines Recall: Atorvastatin 20mg & 80mg Tablets from Sun Pharma Due to Stability Concerns
Sun Pharma UK Limited has issued a precautionary recall of specific batches of their Atorvastatin 20mg…
Swissmedic Opens Dynamic Role in Information & Documentation Services
Swissmedic has announced a compelling opportunity for professionals within clinical, quality, and regulatory sectors. The agency…
Swissmedic Reports Adverse Events from Immunization in 2024: Key Insights
On November 5, 2025, Swissmedic released a comprehensive annual report detailing adverse events following immunization (AEFI)…
HHS Updates Hormone Therapy Guidelines: Removing Misleading FDA Warnings for Women’s Health
The U.S. Department of Health and Human Services (HHS) has taken a pivotal step forward in…
Medicine Recall: Zambon SpA Issues Precautionary Withdrawal of Emylif 50mg Film Over Stability Concerns
Zambon SpA has issued a recall of its Emylif 50mg orodispersible film as a precautionary measure…
Regulatory Update: Swissmedic Confirms Morphinum Capsule Integrity Issues
On November 10, 2025, Swissmedic issued an important notification regarding Sevre-Long® (morphinum), a prescription medication commonly…