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The FDA has assigned a supplemental Biologics License Application submitted by Regeneron and Sanofi for Dupixent in the treatment of COPD with type 2 inflammation with a PDUFA date of June 27, 2024.

Murray Aitken, Executive Director of the IQVIA Institute for Human Data Science, discusses key findings from their Global Use of Medicines 2024 report as well as the significant projected growth in spending and growth in diabetes and global obesity

SKYTyphoid showed a positive immunogenicity and safety profile compared to other polysaccharide-protein conjugate typhoid vaccines that obtained prequalification certification by the World Health Organization.

Letter emphasizes the need to protect children from potentially harmful medical advice spread on social media.

Early-stage trial results indicate that NLRP3 inflammasome inhibitors were able to achieve nearly the same weight loss as Wegovy while also reducing inflammatory biomarkers linked to heart disease.

Ocifisertib is a first-in-class, novel PLK4 inhibitor that has demonstrated significant activity as a monotherapy in both solid and liquid tumors.

The Gilead Sciences CEO will be joined by new board members from Pfizer and Sanofi.

Papa will take over the over effective immediately.

The FDA assigned the biologics license application for linvoseltamab to treat relapsed/refractory multiple myeloma with a Prescription Drug User Fee Act of August 22, 2024.

Injectable long-acting Cabenuva (cabotegravir + rilpivirine) produced superior efficacy in viral load suppression compared with daily oral antiretroviral therapy in patients with HIV who have adherence challenges.

TEV-’574 has shown potential as a treatment for inflammatory bowel diseases such as ulcerative colitis and Crohn disease.

Merck seeks approval for Keytruda (pembrolizumab) plus chemotherapy with carboplatin and paclitaxel for patients with primary advanced or recurrent endometrial carcinoma, alongside chemotherapy (carboplatin and paclitaxel).

Tecvayli is an off-the-shelf bispecific antibody previously granted accelerated approval by the FDA for adults with relapsed/refractory multiple myeloma.

Researchers highlight several benefits and concerns associated with the launch of direct-to-consumer models for GLP-1 receptor agonists.

Amtagvi is the first one-time, individualized T-cell therapy approved by the FDA for any solid tumor cancer.

Planning for a post-recession scenario is essential, ensuring companies are prepared to scale up when funding permits.

The FDA has assigned a Prescription Drug User Fee Act action date of August 20, 2024, for Servier’s New Drug Application for vorasidenib.

The FDA assigned the supplemental new drug application for Krazati (adagrasib) plus cetuximab in patients with locally advanced or metastatic colorectal cancer with a Prescription Drug User Fee Act goal date of June 21, 2024.

The FDA set a Prescription Drug User Fee Act date during Q4 of 2024 for the biologics license application for datopotamab deruxtecan in patients with previously treated advanced nonsquamous non-small cell lung cancer.

Amid shifting healthcare cost strategies, how manufacturers can apply past lessons to best support patients and help boost drug adherence.

The FDA has also approved Tagrisso (osimertinib) as a monotherapy for the first-line treatment of patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC), locally advanced or metastatic EGFR T790M mutation-positive NSCLC, and adjuvant treatment of early-stage EGFRm NSCLC.

Amtagvi (lifileucel) becomes the first and only one-time, individualized T cell therapy to gain FDA approval for a solid tumor cancer.

Positive Phase III study results for Tonmya (cyclobenzaprine HCl sublingual tablets) will be basis of New Drug Application to the FDA for the management of fibromyalgia.

Novartis’ and Roche’s Xolair (omalizumab) is indicated to treat severe allergic reactions after accidental exposure to one or more foods in individuals aged one year and above.

In an interview with Pharm Exec Associate Editor Don Tracy, Raj Verma, Chief Diversity, Culture, and Experience Officer, Sanofi, discusses features of the company's support program for patients diagnosed with cancer and other critical illnesses.

The FDA previously granted accelerated approval to Tepmetko for metastatic non–small cell lung cancer harboring MET exon 14 skipping alterations.

Investigators harness machine learning to evaluate response to sertraline treatment for major depressive disorder.

Looking to hold an advisory board? Here are a few suggestions.