On November 14, 2025, Swissmedic officially announced the first regulatory authorization of Pylclari®, marking an important…
Category: Switzerland
Switzerland updates on medical device regulation and quality.
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…
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)…
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…
Swissmedic Announces Extension of Indication for Retsevmo®: Regulatory Update
On November 7, 2025, Swissmedic officially announced the extension of the therapeutic indication for Retsevmo®, a…
Swissmedic Annual Report: GCP Inspections in Clinical Trials Highlight Key Compliance Areas
Swissmedic has released its annual report detailing the results of clinical trial inspections conducted as part…
Swissmedic Approves PulmoProDiff®: A Notable Step in Respiratory Diagnostics
Swissmedic has announced the official authorisation of PulmoProDiff®, marking a critical milestone in respiratory diagnostic technology.…