ALS News Today22h
EMA’s CHMP upholds its negative opinion on masitinib for ALS
The opinion rejects granting conditional marketing authorization to AB Science’s masitinib as an oral add-on treatment for ...
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 ...
Pharmabiz2h
EMA committee recommends approval of LINDIS Biotech’s Korjuny to treat malignant ascites MA in adults with EpCAM-positive carcinomas
EMA committee recommends approval of LINDIS Biotech’s Korjuny to treat malignant ascites MA in adults with EpCAM-positive carcinomas: Munich, Germany Wednesday, October 23, 2024 ...
BioWorld2d
CHMP nods for Korjuny, Alhemo; no, again, for Translarna, masitinib
The first bispecific antibody to win regulatory approval is about to make a comeback 10 years after being taken off the market in Europe for commercial reasons. Catumaxomab, then called Removab, and ...
Novartis Announces Positive CHMP Opinion For Kisqali - Quick Facts
Novartis announced the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion ...
Pharmabiz5h
EMA committee recommends extended authorization for BeiGene’s Tevimbra to treat gastric or gastroesophageal junction cancer & ESCC
EMA committee recommends extended authorization for BeiGene’s Tevimbra to treat gastric or gastroesophageal junction cancer & ESCC: San Mateo, California Wednesday, October 23, ...
Medscape4d
EMA Authorizes Korjuny for Malignant Ascites
The European Medicines Agency has recommended Korjuny for the treatment of patients with intraperitoneal malignant ascites.
Medindia4d
Novartis receives positive CHMP opinion for Kisqali® to help reduce risk of recurrence in people with HR+/HER2- early breast cancer
If approved, patients in Europe with stage II or III HR+/HER2- early breast cancer (EBC) at high risk of recurrence, including those with node-negative disease, will be eligible ...
ThePrint3d
Accord Healthcare receives positive CHMP opinion for IMULDOSA®, ustekinumab biosimilar to Stelara®
Accord Healthcare Limited (Accord) announces that the Committee for Medicinal Products for Human Use (CHMP) of the European ...