Femasys (FEMY) announces Conformite Europeene mark certification under European Union Medical Device Regulation as the first regulatory ...

The European orphan drug market is growing and is already comparable in size and scope to the US market. The European Union ...

The efficiency of the approval process ... are successful, the EMA plans to extend systematic monitoring into 2025 to maintain improvements. The 5th Medical Device Software Development Summit ...

The global preclinical medical device testing services market is poised for steady expansion, with revenue expected to grow from USD 1,696.0 million in 2025 to USD 2,842.1 million by 2035, at a CAGR ...

Dr. Dina Radenkovic, CEO of Gameto, discusses the key considerations for bringing iPSC-based fertility treatments to market from a regulatory and manufacturing perspective.

Post-authorisation safety studies (PASS) are often seen simply as a regulatory necessity, a checkbox that ensures ongoing ...

Obtaining the Marketing Authorisation Application (MAA) is a key step in the commercialization of drugs in the EU, and also an important help to promote the global market expansion of pharmaceutical ...

Pfizer's Covid-19 vaccine is considered by healthcare authorities to be safe and effective, with data gathered from billions ...

Discover how outsourcing regulatory submission content development improves efficiency and ensures compliance.

This new approach offers clear potential benefits for medicine and device developers ... a completed JSA is required six months after EMA approval. Yet, it can take three months just to receive ...

Anew Health plans a $20M IPO amid slowing revenue growth and market challenges. Discover insights on its expansion plans and ...