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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.

This acquisition will add asthma treatment A1O-001 to GSK’s portfolio.

The Federal Trade Commission and Department of Health and Human Services are examining the practices of group purchasing organizations and drug wholesalers and the role they may play in triggering shortages of generic medications.

Lymphir is an immunotherapy under evaluation for the treatment of patients with relapsed/refractory cutaneous T-cell lymphoma following at least one previous line of systemic therapy.

The MightySat Fingertip Pulse Oximeter is reportedly the first pulse oximeter available without a prescription.

Device designed to address tricuspid regurgitation through a vein in the leg.

The campaign, that started in 2012, is back with seven new faces—many of which included messaging about the harms of menthol cigarettes.

Treatment aims to reduce the risk of finger or toe amputation due to frostbite.

Augtyro is a potential best-in-class tyrosine kinase inhibitor that targets ROS1- or NTRK-positive locally advanced or metastatic solid tumors.

Pancreatic adenocarcinoma is the most common form of pancreatic cancer, with more than 60,000 diagnoses per year in the United States.

Researchers find that a thorough evaluation of drug spending and value can lead to a better allocation of healthcare resources.

Roche halts agreement with Repare Therapeutics to develop and commercialize camonsertib just weeks after triggering a $40 million milestone payment when the first patient was dosed with the novel cancer drug.

BXCL701 is an oral innate immune activator being investigated in combination with Keytruda (pembrolizumab) in patients with metastatic small cell neuroendocrine prostate cancer.

In this video interview with Pharm Exec Associate Editor Miranda Schmalfuhs, Dr. Jo Varshney, CEO & Founder of VeriSIMLife, discusses how artificial intelligence and machine learning can assist in the drug shortage problem.

In clinical trials, bepirovirsen showed the potential to address a significant unmet medical need for patients with chronic hepatitis B by reducing hepatitis B surface antigen levels and HBV DNA.

Takeda expects Eohilia single-dose stick packs will be available by the end of February for patients aged 11 years and older with eosinophilic esophagitis.

The FDA granted accelerated approval to Elahere in November 2022 for adults with folate receptor-alpha-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.

The use of artificial intelligence (AI) in drug development has been hampered by issues that have caused a gap between AI’s potential and its full utilization in this space.

Joint venture aims to submit an Investigational New Drug application to the FDA by early next year for treatment that targets solid tumors.