Articles

A trial set out to determine whether empagliflozin can help prevent hospitalizations and extend life for patients with heart failure, while not hurting the US payers’ pockets. 

Calculating the Cost-Effectiveness of Empagliflozin in Patients Experiencing Heart Failure 

Regeneron Pharmaceuticals’ linvoseltamab is currently in clinical development to treat adult patients with relapsed/refractory multiple myeloma who experienced disease progression following prior administration of at least three therapies.

FDA Grants Priority Review to Novel Bispecific Antibody for Multiple Myeloma 

Cabenuva (cabotegravir + rilpivirine) showed superior efficacy in maintaining viral load suppression in patients with HIV compared with standard of care daily oral antiretroviral treatment.

Long-Acting Injectable Cabenuva Found More Effective Than Daily ART at Suppressing HIV in Patients With Adherence Challenges

Phase III results from Keytruda (pembrolizumab)’s NRG-GY018 trial help influence the agency’s decision.


Merck’s Primary Advanced, Recurrent Endometrial Carcinoma Treatment Given Priority Review by FDA

Tecvayli (teclistamab-cqyv) was the first bispecific antibody to gain FDA approval for the treatment of multiple myeloma.

FDA Approves Tecvayli at Reduced Dosing Frequency for Relapsed/Refractory Multiple Myeloma 

Arshad M. Khanani, MD, MA, FASRS, will help lead development efforts for sozinibercept, a potential wet AMD treatment. 

Opthea Hires New Chief Medical Advisor

As part of the agreement, Novo will be paid both development and commercial milestone payments for NN-8828, is currently in Phase II of non-dermatological indications. 

Almirall, Novo Nordisk Reach Licensing Agreement Surrounding IL-21 Blocking Monoclonal Antibodies

The FDA has assigned Servier’s New Drug Application for vorasidenib to treat IDH-mutant gliomas with a Prescription Drug User Fee Act action date of August 20, 2024.

FDA Accepts, Grants Priority Review to NDA for Vorasidenib in IDH-Mutant Gliomas

FDA accepts Bristol Myers Squibb's application for Krazati (adagrasib) plus cetuximab for patients who received prior treatment for KRASG12C-mutated locally advanced or metastatic colorectal cancer.

Krazati Combination for Advanced, Metastatic Colorectal Cancer Granted FDA Priority Review

The agency will make its final decision surrounding the locally advanced or metastatic nonsquamous NSCLC drug —based on results from the TROPION-Lung01 Phase III trial—by Q4 2024.
 


News