The CHMP of the regulatory body in the EU adopts a positive opinion recommending the approval of Novo Nordisk's Alhemo for ...

BeiGene (BGNE) announced that the Committee for Medicinal Products for Human Use – CHMP – of the European Medicines Agency issued ...

Regulatory News: ABIONYX Pharma, (FR0012616852 - ABNX - PEA PME eligible), a new generation biotech company dedicated to the ...

The fully-owned Intas Pharmaceuticals subsidiary Accord Healthcare has announced that the Committee for Medicinal Products ...

Gilead Sciences, the maker of a twice-a-year anti-HIV injection, has approached South Africa’s medicine regulator to discuss ...

Leerink Partners analyst Joseph Schwartz has maintained their neutral stance on PTCT stock, giving a Hold rating on October 11. Joseph ...

Learn how to effectively navigate the challenges of CMC in breakthrough drug development. Discover key strategies here.

Dong-A ST (President/CEO Jae-Hun Jung, KRX:170900) announced on October 18 th that its biosimilar IMULDOSA ® (active ingredient: ustekinumab, development code DMB-3115), referencing Stelara ®, has ...

Evergreen Theragnostics opens trial of 68Ga-EVG321 for patients with small cell lung cancer in European Union: Springfield, New Jersey Monday, October 21, 2024, 18:00 Hrs [IST] Ev ...

Christian Meyer and Gisela Grabow of Maiwald discuss potential changes to the EU pharmaceutical regulation and their ...

Healthcare decision-makers are facing significant challenges that will intensify in the coming years as they work to address ...