On November 14, 2025, Swissmedic officially announced the first authorization of DATROWAY®, marking an important step…
Category: Europe
europe 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…
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)…
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…
Swissmedic Issues Recall for Amoxicillin OrPha 1g Due to Quality Concerns
Swissmedic has announced a recall of batch B323BE of Amoxicillin OrPha 1g powder for injection or…
First Swissmedic Authorisation for KIMMTRAK®: A Key Milestone in Oncology Therapy
Swissmedic has released a pivotal regulatory announcement regarding the authorisation of KIMMTRAK®, marking its first approval…