Drug diversion remains a persistent challenge for hospitals and health systems, putting both patient safety and workforce wellbeing at risk. The impact doesn’t stop there – diversion can also create significant operational setbacks and unexpected financial and reputational costs. Strong…
Pharmacy
The FDA is considering changes that could reshape how vaccines move from labs to American pharmacies — the most significant proposed shift in vaccine oversight since the early 2000s. While the agency has not formally issued draft guidance, recent public…
The FDA has approved Augmentin XR, an oral antibacterial, under its Commissioner’s National Priority Voucher pilot program, marking the first approval granted through the expedited review pathway. The approval met the program’s target two-month timeline and fulfilled criteria by supporting…
Eli Lilly will build a $6 billion new facility in Huntsville, Ala., to manufacture active pharmaceutical ingredients for small molecule and peptide medicines, including the company’s oral GLP-1 candidate, orforglipron. The site will support domestic production of therapies and strengthen pharmaceutical…
The FDA has approved Waskyra (etuvetidigene autotemcel), the first gene therapy for Wiskott-Aldrich syndrome, a rare and life-threatening immune disorder. Waskyra is indicated for pediatric patients 6 months and older, as well as adults with Wiskott-Aldrich syndrome who are eligible…
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The FDA has expanded its internal review of potential COVID-19 vaccine-related deaths to include adults, building on an inquiry that initially focused on children. The broadened review follows sustained pressure from HHS Secretary Robert F. Kennedy Jr. and growing political…
Pfizer has entered into a global collaboration and license agreement with YaoPharma for the development, manufacturing and commercialization of YP05002, a small-molecule GLP-1 receptor agonist currently in phase 1 development for chronic weight management. YaoPharma, a subsidiary of Shanghai Fosun…
The FDA has launched a safety review of approved respiratory syncytial virus therapies for infants, including Beyfortus from Sanofi and AstraZeneca and Enflonsia from Merck, Reuters reported Dec. 9. Senior executives from the three companies were informed last week that…
Nearly 4 million Medicare-eligible Americans face heightened risk of disrupted medication access as restructuring efforts by the U.S. Postal Service slow mail delivery in rural and underserved communities reliant on mail-order prescriptions, according to a Dec. 4 analysis from The…
The FDA has recalled multiple lots of a blood pressure medication sold under the brand name Ziac, according to a Dec. 6 report from USA Today. The medication — bisoprolol fumarate and hydrochlorothiazide tablets — is manufactured by Glenmark Pharmaceuticals…