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Vertex Receives CHMP Positive Opinion for KALYDECO® for the Treatment of Infants With Cystic Fibrosis Ages 1 Month and Older - Vimarsana News

Vertex Receives CHMP Positive Opinion for KALYDECO® for the Treatment of Infants With Cystic Fibrosis Ages 1 Month and Older

- 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...

Bristol Myers Squibb Receives Positive CHMP Opinion for Reblozyl® (luspatercept) for Treatment of Adults with Transfusion-Dependent Anemia due to Low- to Intermediate-Risk Myelodysplastic Syndromes (MDS) - Vimarsana News

Bristol Myers Squibb Receives Positive CHMP Opinion for Reblozyl® (luspatercept) for Treatment of Adults with Transfusion-Dependent Anemia due to Low- to Intermediate-Risk Myelodysplastic Syndromes (MDS)

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...

EMA Approves Tx for Psoriasis and Other Autoimmune Disorders - Vimarsana News

EMA Approves Tx for Psoriasis and Other Autoimmune Disorders

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

Legend Biotech Announces Positive CHMP Opinion for CARVYKTI® (ciltacabtagene autoleucel) for the Treatment of Patients with Relapsed and Lenalidomide Refractory Multiple Myeloma in Earlier Lines of Therapy - Vimarsana News

Legend Biotech Announces Positive CHMP Opinion for CARVYKTI® (ciltacabtagene autoleucel) for the Treatment of Patients with Relapsed and Lenalidomide Refractory Multiple Myeloma in Earlier Lines of Therapy

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 ...

Biogen's QALSODY® (tofersen), the First Therapy to Treat Rare, Genetic Form of ALS, Received Positive Opinion from CHMP -February 23, 2024 at 07:01 am EST - Vimarsana News

Biogen's QALSODY® (tofersen), the First Therapy to Treat Rare, Genetic Form of ALS, Received Positive Opinion from CHMP -February 23, 2024 at 07:01 am EST

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...