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The FDA’s Vaccines and Related Biological Products Advisory Committee (VBRPAC) will review the biologics license application for Heplisav-B (hepatitis B vaccine, recombinant [adjuvanted], Dynavax Technologies Corporation) at a meeting scheduled for November 16.

The FDA has given the green light to pembrolizumab (Keytruda, Merck), an anti-programmed death receptor-1 (PD-1) therapy, at a fixed dose of 200 mg administered every three weeks for the treatment of patients with recurrent or metastatic head-and-neck squamous cell carcinoma (HNSCC) with disease progression during or after platinum-containing chemotherapy

Seven men who were treated with Cialis (tadalafil) tablets for erectile dysfunction have sued Indianapolis-based Eli Lilly and Co., claiming that they later developed skin cancer that was related to the medication, according to a report in the Indianapolis Business Journal.

A study of four common medical conditions suggests that hospitals that used intensive care units (ICUs) more frequently were more likely to perform invasive procedures and have higher costs while showing no improvement in mortality, according to an article posted on the Medical Xpress website.

Check-Cap Ltd., a medical diagnostics company based in Israel, has entered into an agreement with GE Healthcare to develop high-volume manufacturing of an x-ray source for Check-Cap’s ingestible capsule for colorectal cancer screening.

Bristol-Myers Squibb has announced that its CheckMate-026 trial, a phase 3 study investigating the use of nivolumab (Opdivo) as monotherapy, did not meet its primary endpoint of progression-free survival (PFS) in patients with previously untreated advanced non–small-cell lung cancer (NSCLC) whose tumors expressed programmed death ligand-1 (PD-L1) at great

Two FDA panels––the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee––have recommended the approval of Arymo ER (Egalet Corporation), an abuse-deterrent, extended-release, oral morphine formulation.

A major goal of hospitals and health systems is to prevent 30-day readmissions among medical and surgical patients with conditions such as chronic obstructive pulmonary disease (COPD), heart failure, and hip and knee replacements.

CVS Health has announced that it is taking a stand against “egregious” drug price increases that unnecessarily add costs for clients and their members.

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