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New Frontline BTK Inhibitor Strategy Gains FDA Approval in Untreated Mantle Cell Lymphoma

Pharmacy Times

Mary Dzhuryan is a class of 2026 PharmD candidate at the USC Alfred E. Mehrnaz Razavi Vakhshoori is a class of 2026 PharmD candidate at the USC Alfred E. The recent application was granted both priority review and orphan drug designation. Mann School of Pharmacy and Pharmaceutical Sciences in Los Angeles.

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Lumateperone Submits Application for Schizophrenia Indication to FDA for Supplemental New Drug

Pharmacy Times

2 Guiding prescribers and patients through initiation of lumatperone, adjusting dosage amounts, and switching from other antipsychotics, emphasizing its favorable relapse reduction profile is key in preventing relapse.

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Real-World Data Shows Similar Clinical Outcomes in Patients Receiving Biosimilars Following Switch From Reference Product

Pharmacy Times

Both Hadlima and Hyrimoz share the same strengths and dosages and have no clinically meaningful differences from Humira when relieving patient symptoms. The most common reason for exclusion was the patient opting out of clinical follow-up with the specialty pharmacy team.

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Sanofi to Begin Globally Shipping Beyfortus Ahead of RSV Season

Pharmaceutical Commerce

Image Credit: Adobe Stock Images/Artur.com Key Takeaways Sanofi is shipping Beyfortus early to ensure strong supply for the 2025–2026 RSV season and avoid past shortages. As of now, supply for this coming season matches last year’s total dosage, with production expected to continue. Beyfortus cut RSV hospitalizations by up to 83.2%

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Looking Beyond mRNA-based COVID-19 Vaccines to Innovative Therapeutics

PharmaTech

It co-developed Comirnaty, the COVID-19 vaccine in partnership with Pfizer, and is gearing up for the commercial launch of its variant-adapted COVID-19 vaccine for the 2025/2026 season, pending regulatory approval. It is also developing BNT165e, an RNA-based vaccine for the prevention of P. falciparum malaria.

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Aenova Adds Cold Chain Warehouse to Latina, Italy Site

PharmaTech

Construction on the new warehouse began in early 2025, and the company expects the facility to be operational in the first quarter of 2026. An expansion of the Latina site’s fill/finish line for biologics is also planned for the future.

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STAT+: Pharmalittle: We’re reading about GLP-1 drugs for addiction, FDA funding, and lots more

STAT

Fixed-dose combinations contain multiple medications in a single dosage form to help simplify treatment for patients. Food and Drug Administration, Senate appropriators unanimously advanced a funding bill last Thursday that maintains agency funding in fiscal 2026 at roughly the same level as in fiscal 2025 , Politico notes.

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