Clinical Development FDA Approval HR Medicine 
The Pharma Data
MAY 26, 2023
Pfizer’s PAXLOVID™ receives FDA approval for adult patients at high risk of progression to severe COVID-19 Pfizer Inc. residents eligible for PAXLOVID will continue to receive the medicine at no charge.* NYSE: PFE) announced today that the U.S. ” COVID-19 continues to cause significant burden in the U.S.
The Pharma Data
JANUARY 20, 2021
FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. Armstrong, cardiologist and Distinguished University Professor of Medicine at the Canadian VIGOUR Centre, University of Alberta, and study chair of the VICTORIA trial. Related Articles: Verquvo (vericiguat) FDA Approval History.
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The Pharma Data
APRIL 28, 2023
Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC), by a vote of 11 to 1 with one abstention, supported FDA approval of LYNPARZA plus abiraterone and prednisone or prednisolone (abi/pred) for the first-line treatment of adult patients with BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC).
Drug Discovery World
JUNE 1, 2023
According to NCBI, most of the ADCs developed so far are for use in the treatment of cancer, but there is plenty of potential for using ADCs to treat other diseases 1. A Nature publication confirmed that there are currently 12 FDA-approved ADCs on the market, and nine of these secured FDA approval in the past six years 2.
XTalks
NOVEMBER 20, 2023
AstraZeneca has won its first-in-class approval for its AKT inhibitor Truqap (capivasertib) in combination with Faslodex (fulvestrant) for treating patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer.
The Pharma Data
JANUARY 15, 2021
This approval represents the first time a HER2 directed medicine has demonstrated a significant improvement in survival compared to chemotherapy for patients following initial treatment in the metastatic setting and it has the potential to become the new standard of care for this patient population.”. 4.3] (HR=0.47; 95% CI 0.31-0.71)
The Pharma Data
SEPTEMBER 9, 2020
In a separate pooled analysis, ENSPRYNG reduced the risk of relapse in the combined double-blind period and open-label extension (OLE) by 51% (HR, 0.49; 95% CI, 0.31–0.79; Roche’s Chief Medical Officer and Head of Global Product Development. ENSPRYNG is approved in Canada, Japan, Switzerland and the U.S.
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