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European Committee for Medicinal Products recommends marketing authorization for Pfizer's EMBLAVEO; the drug treats complicated intra-abdominal infections, hospital-acquired pneumonia, and complicated urinary tract infections
Published: March 22, 2024 by U.S. Markets (Alternative Disclosure) via PUBT
Novartis AG gets positive opinion from CHMP for Fabhalta paroxysmal nocturnal hemoglobinuria treatment for adults; the therapy awaits final European Commission approval in the next two months, potentially becoming Europe's first oral monotherapy for PNH
Published: March 22, 2024 by dpa-AFX International Compact
Biogen's QALSODY, a treatment for the rare genetic form of ALS known as SOD1-ALS, receives a positive recommendation from CHMP; if approved, QALSODY would become the first treatment to target a genetic cause of ALS in the EU
Published: February 23, 2024 by GlobeNewswire Europe
CHMP recommends approval of Bristol Myers' Reblozyl for adult patients with transfusion-dependent anemia due to myelodysplastic syndromes; if approved by the European Commission, it would represent the fourth authorized indication for Reblozyl in the EU
Published: February 23, 2024 by Bristol-Myers Squibb Co.
CHMP recommends approval of Janssen's CARVYKTI cilta-cel for earlier treatment of relapsed and refractory multiple myeloma; this marks the first time a CAR-T therapy has received a positive CHMP opinion for this patient population post first relapse
Published: February 23, 2024 by Janssen Pharmaceutical Companies

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