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news.Roche gets FDA nod for Evrysdi to treat spinal muscular atrophy
Evrysdi is a survival of motor neuron 2 (SMN2) splicing modifier created for the treatment of SMA caused by mutations in chromosome 5q, which lead to SMN protein
Evrysdi is a survival of motor neuron 2 (SMN2) splicing modifier created for the treatment of SMA caused by mutations in chromosome 5q, which lead to SMN protein
There are no HER3 directed therapies approved for the treatment of NSCLC or any cancer. The frequency of HER3 overexpression in EGFR-mutated NSCLC has been reported to be
The approval will enable ViiV Healthcare to use the complete regimen as a replacement for the current antiretroviral (ARV) regimen in adults who are virologically suppressed on a
The results were reviewed by an independent Data Monitoring Committee (DMC) at a planned interim analysis. The safety profile for lorlatinib and crizotinib were consistent with what has
BLENREP has been approved as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma who have secured at least four prior therapies including an anti-CD38
HEPCLUDEX has been approved as the first treatment option for adult patients with chronic hepatitis delta virus infection and compensated liver disease in Europe. The drug was originally
Sisunatovir is an orally administered fusion inhibitor designed to inhibit RSV replication by suppressing RSV F-mediated fusion of RSV with the host cell. RSV is a respiratory pathogen
The study will include up to 2,400 participants and assess the ability of LY-CoV555 to prevent infection of long-term care residents and facility staff who have been exposed
The studies indicated that the Depakine has induced disabilities in about 15,000 to 30,000 children whose mothers took the drug valproate during pregnancy. The drug, which has been
The supplemental Biologics License Application (sBLA) for Tecentriq was granted under priority review. The review was also conducted under Project Orbis, an initiative of the FDA Oncology Center