FDA lists a once-weekly insulin approval for pediatric type 2 diabetes
The FDA's notable approvals list records its decision for Awiqli on October 23.
Read the FDA list ↗LENTOTECH / PHARMA INTELLIGENCE
News & intelligence
Follow regulatory decisions, medicines and manufacturing developments. Each item links to its original source; dates identify the source entry or meeting.
EMA committee recommends six medicines for approval
The October CHMP meeting included positive opinions for medicines across several therapeutic areas. The recommendations are subject to a European Commission decision.
Read the EMA report ↗A practical starting point for API manufacturing and CDMO selection
Questions to use when discussing process knowledge, quality systems and technology transfer with potential partners.
Read the guide ↗