Page 16 - Human Use News Today

- If approved, KALYDECO® will be the first and only medicine approved in Europe to treat the underlying cause of cystic fibrosis in babies as young as 1 month with specific mutations in the CFTR...

Approval by European Commission would expand Reblozyl’s indication to include first-line treatment of anemia in adults with MDS in Europe In the pivotal Phase 3 COMMANDS study, Reblozyl nearly...

The biosimilar Pyzchiva is highly similar to Stelara, which was approved in the EU in 2009.

CARVYKTI® is the first CAR-T therapy for patients with relapsed and refractory multiple myeloma to receive a positive CHMP opinion for second line treatment ...

SOD1-ALS is a devastating, uniformly fatal, and ultra-rare genetic form of ALS affecting less than 1,000 people in Europe1With QALSODY, Biogen has advanced the role of neurofilament in the development...

By Adriano Marchese Vertex Pharmaceuticals said Friday that its treatment for cystic fibrosis was given a positive opinion by European Union regulators to treat infants with specific mutations...

Merck announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency has given a positive opinion recommending the approval of Keytruda + platinum-based...

Drug major Merck & Co., Inc. (MRK) announced Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP adopted a positive opinion recommending approval of its anti-PD-1 therapy KEYTRUDA, in combination with platinum-containing chemotherapy.

Bristol Myers Squibb announces that it has received a positive opinion from the CHMP for Reblozyl in the treatment of adults with transfusion-dependent anemia due to low- to intermediate-risk...

By Colin Kellaher Bristol Myers Squibb on Friday said the European Medicines Agencys Committee for Medicinal Products for Human Use recommended approval of its anemia drug Reblozyl. The...