Widaplik, a Single Pill, Triple Combo Therapy for Hypertension, Gets FDA Approval
Widaplik is indicated for the treatment of hypertension, including as initial treatment, to lower blood pressure.
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RFK Jr Selects 8 New Members for CDC’s Vaccine Advisory Panel
The announcement, which was made on X, lists the 8 new members and their credentials.
Mavyret Indication Expanded to Include Treatment of Acute Hepatitis C Virus
Mavyret is a fixed dose combination of the direct-acting antiviral agents, glecaprevir, a HCV NS3/4A protease inhibitor, and pibrentasvir, an HCV NS5A inhibitor.
HHS Secretary RFK Jr Fires All 17 Members of CDC Vaccine Advisory Committee
The ACIP is a federal advisory committee composed of medical and public health experts who make recommendations on the use of vaccines for adults and…
Enflonsia Approved for RSV Disease Prevention in Infants
Enflonsia is an extended half-life RSV fusion glycoprotein neutralizing monoclonal antibody.
Nubeqa Approval for Metastatic Castration-Sensitive Prostate Cancer Expanded
The approval was supported by data from the randomized, double-blind, placebo-controlled, phase 3 ARANOTE trial.
FDA Drug Approval Decisions Expected in July 2025
The FDA is expected to decide on treatments for multiple myeloma, NSCLC, melanoma, phenylketonuria, and 2 rare kidney diseases.
FDA Approves Moderna’s Next-Generation COVID-19 Vaccine mNexspike
The new vaccine is indicated for individuals who have been previously vaccinated with any COVID-19 vaccine and are 65 years or older, or 12 to…
Atacicept Significantly Reduces Proteinuria in IgA Nephropathy Trial
Atacicept is an investigational BAFF (B-cell activating factor)/APRIL (a proliferation-inducing ligand) dual inhibitor.
Calpain-2 Targeting Antisense Oligonucleotide Fast Tracked for ALS
A phase 1 trial, LUMINA, is currently underway and is evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of AMX0114 in approximately 48 patients with ALS.