News

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

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

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

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

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.

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 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.

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.

The lack of transparency in the pharmaceutical industry further exacerbates the challenges faced by consumers.

Tagrisso (osimertinib) approved for use in combination with platinum-based chemotherapy in adults with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer harboring EGFR exon 19 deletions or exon 21 L858R mutations.

Iovance’s Amtagvi (lifileucel) gains FDA accelerated approval for adults with unresectable or metastatic melanoma.

The partnership revolves around meeting various agency standards and industry requirements pertaining to the drug development and manufacturing lifecycle.

The new seals include sustainable film material containing recyclate content of up to 90%.

Xolair (omalizumab) was previously granted FDA Priority Review status and Breakthrough Therapy Designation to prevent severe allergic reactions after accidental exposure to one or more foods in people with allergies.

Strategic and proactive thinking are vital in providing supply chain leaders with an opportunity to shift their focus to a more holistic, value-centered approach.

Tepmetko (tepotinib), an oral MET inhibitor, was granted accelerated approval in 2021 for metastatic non–small cell lung cancer harboring MET exon 14 skipping alterations.

Personalized medicine approaches, informed by predictive modeling, could optimize treatment outcomes and reduce patient burden and costs.

The financial commitment features construction of new warehouses in Pennsylvania and North Carolina.

The Masimo product is expected to address a significant gap in the market for dependable home-use medical devices.

Scientists develop algorithms that can not only identify tumors that will respond well to chemotherapy, but which are also likely to resist treatment.

Powered by evidence from the TRILUMINATE trial, Abbott's TriClip System’s benefits outweighed its risks, which led to the group’s positive recommendation.

The Federal Trade Commission and the Department of Health and Human Services are seeking public input to evaluate how policymakers can address chronic drug shortages and promote a resilient supply chain.

There were no safety or efficacy issues identified in the FDA complete response letter for Lymphir, with no additional trials required.

Patients with severe frostbite who were administered Aurlumyn monotherapy experienced a significantly reduced risk of the need for amputation.

Augtyro was previously approved in November 2023 to treat locally advanced or metastatic ROS1-positive non-small cell lung cancer.

Onivyde (irinotecan liposome injection) in combination with oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX) was found to improve overall survival in metastatic pancreatic adenocarcinoma.

Properly supporting market access for a newly launched product with a single indication is challenging. Doing so for multiple indications, or supporting subsequent indications, can have a compounding effect on the degree of difficulty for getting everything right.

Analysis explores where drug prices are derived from, and whether a holistic societal approach can help determine these products’ true value.

Bruce Phelan of Blue Fin discusses Novo Nordisk's purchase of Catalent manufacturing sites to increase its ability to meet the demand for the popular weight loss drug Wegovy.

Examination evaluates investigational stem cell interventions, including how the states have implemented their own policies when it comes to their uses.