The FDA has delayed approval of Aquestive Therapeutics’ new drug application seeking approval of Anaphylm, a sublingual epinephrine film for the treatment of Type 1 allergic reactions, including anaphylaxis. The agency issued a complete response letter Jan. 30, citing deficiencies…
Pharmacy
The FDA began accepting requests Feb. 1 to participate in its PreCheck pilot program, an initiative aimed at streamlining regulatory review for new U.S.-based pharmaceutical manufacturing facilities. The pilot is designed to increase regulatory predictability and support earlier engagement with…
The Pennsylvania State University in University Park filed a federal lawsuit Jan. 13 alleging major insulin manufacturers and pharmacy benefit managers artificially inflated the price of insulin nationwide. The complaint alleges Eli Lilly, Novo Nordisk and Sanofi — which controlled…
Becker’s asked pharmacy executives from hospitals and health systems across the U.S. to share their top 2026 priority for balancing financial or operational stability with growth in mind. The 12 executives featured in this article are all speaking at the…
As cancer care becomes increasingly driven by complex, high-cost therapies, health systems are rethinking how tightly oncology and pharmacy are integrated. At Mount Sinai Medical Center in Miami Beach, Fla., leadership sees pharmacy not as a downstream support function but…
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The Labor Department’s Employee Benefits Security Administration proposed regulation Jan. 29 that would require pharmacy benefit managers to disclose their compensation with self-insured group health plans. Under the rule, PBMs would have to share information on their rebates and other…
Civica, a nonprofit drug manufacturer, offers more than 70 generic sterile injectables and has a member base of more than 50 hospitals and health systems. Health systems representing 500 hospitals and a few philanthropic organizations founded Civica in 2018 to…
After finding an intraventricular tumor in one clinical trial participant, the FDA placed a clinical hold on an experimental gene therapy developed by Regenxbio, a Rockville, Md.-based biotech company. Regenxbio said in a Jan. 28 news release the patient is…
HHS has rescinded a civil rights guidance directed at the nation’s retail pharmacies, reversing a directive that outlined their legal obligations to dispense medications tied to reproductive health. HHS’ Office for Civil Rights withdrew its September 2023 guidance, which had…
Glendale-based Ascension Wisconsin has expanded its Dispensary of Hope program to four pharmacies, ABC affiliate WISN reported Jan. 28. The program is now available at nine Ascension pharmacy locations, with two new sites in Franklin and one each in Elmbrook,…