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Top News In Global Product Development At Genentech Today - Breaking & Trending Today

Inavolisib Plus Palbociclib/Fulvestrant Earns FDA Priority Review for Advanced HR+/HER2–, PIK3CA+ Breast Cancer

The FDA granted priority review to inavolisib plus palbociclib/fulvestrant for HR-positive, HER2-negative, advanced breast cancer with PIK3CA mutations. ....

Levi Garraway , European Medicines Agency , Global Product Development At Genentech , Prescription Drug User Fee , Global Product Development , European Medicines ,

Inavolisib Receives FDA Breakthrough Therapy Designation for PIK3CA-Mutated, HR+/HER2–Breast Cancer

Inavolisib/palbociclib/fulvestrant was granted FDA granted breakthrough therapy designation for PIK3CA-mutated, HR-positive/HER2-negative breast cancer. ....

Levi Garraway , Global Product Development At Genentech , Global Product Development ,

FDA Approves Adjuvant Alectinib for ALK+ Early-Stage NSCLC

The FDA has approved alectinib as adjuvant treatment in select patients with ALK-positive non–small cell lung cancer. ....

Genentech Alecensa , Levi Garraway , Global Product Development At Genentech , Global Product Development ,

Inavolisib Plus Palbociclib and Fulvestrant Improves PFS in PIK3CA-Mutated HR+ Breast Cancer

The addition of inavolisib to palbociclib and fulvestrant improved progression-free survival vs palbociclib and fulvestrant alone in select patients with PIK3CA-mutated, hormone receptor–positive, HER2-negative, locally advanced or metastatic breast cancer. ....

Levi Garraway , Global Product Development At Genentech , Global Product Development , Inavolisib , Inavolisib Plus Palbociclib And Fulvestrant , Breast Cancer , Pik3ca Mutated Hr Breast Cancer , Phase 3 Inavo120 Trial ,

Faricimab (Vabysmo) Receives FDA Approval for Retinal Vein Occlusion

Genentech announced the FDA had approved faricimab-svoa (Vabysmo) for retinal vein occlusion on October 26, 2023, which marks the third ophthalmic indication for the bispecific antibody. ....

Levi Garraway , Genentech Vabysmo , Drug Administration , Global Product Development At Genentech , Global Product Development , Biologics License Application , Retinal Vein Occlusion , Four Months , People With Retinal Vein Occlusion , Faricimab Vabysmo , Vabysmo For Rvo ,