BeiGene receives positive CHMP opinions for tevimbra in gastric cancers
BeiGene (BGNE) announced that the Committee for Medicinal Products for Human Use – CHMP – of the European Medicines Agency issued ...
NVO's Alhemo Gets Positive CHMP Opinion in EU for Haemophilia A or B
The CHMP of the regulatory body in the EU adopts a positive opinion recommending the approval of Novo Nordisk's Alhemo for ...
ABIONYX Pharma Received Positive Feedback from the EMA for CER-001 in LCAT Deficiency
Regulatory News: ABIONYX Pharma, (FR0012616852 - ABNX - PEA PME eligible), a new generation biotech company dedicated to the ...
The Pharma Letter5h
Accord’s Stelara biosimilar Imuldosa wins positive CHMP recommendation
The fully-owned Intas Pharmaceuticals subsidiary Accord Healthcare has announced that the Committee for Medicinal Products ...
CHMP Recommends the Approval of Dong-A ST’s IMULDOSA, a Biosimilar to Stelara®
Dong-A ST stated that its R&D expertise has been reaffirmed by the positive CHMP opinion, following the FDA approval for ...
News249h
Talks have started to get the twice-yearly anti-HIV jab registered in SA
Gilead Sciences, the maker of a twice-a-year anti-HIV injection, has approached South Africa’s medicine regulator to discuss ...
Hold Rating for PTC Therapeutics Amidst Regulatory Hurdles with Translarna
Leerink Partners analyst Joseph Schwartz has maintained their neutral stance on PTCT stock, giving a Hold rating on October 11. Joseph ...
News Medical15h
How to navigate chemistry, manufacturing, and controls (CMC ) challenges in breakthrough drug development
Learn how to effectively navigate the challenges of CMC in breakthrough drug development. Discover key strategies here.
Pharmabiz15h
Evergreen Theragnostics opens trial of 68Ga-EVG321 for patients with small cell lung cancer in European Union
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 ...
Managingip.com15h
EU pharmaceutical reforms propose changes to regulatory protection periods
Christian Meyer and Gisela Grabow of Maiwald discuss potential changes to the EU pharmaceutical regulation and their ...
Lindis Biotech GmbH: LINDIS Biotech Receives Positive CHMP Opinion for KORJUNY in the European Union
Upon authorization by the European Commission, KORJUNY® will be the only drug approved and available for the intraperitoneal treatment of malignant ascites in adults with epithelial cell adhesion mole ...