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October 2nd, 2026

Amino Acid Count Determines Retatrutide's Biologic or Drug Classification

LumaLex Law's Dustin Robinson explains why retatrutide compounding remains illegal regardless of the Seventh Circuit's pending classification ruling.

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October 1st, 2026

FDA Warns Fresenius Kabi Over Sterile Injectable Contamination

Patients suffered pyrogenic reactions before Fresenius Kabi recalled 3 contaminated batches at its 430,000-sq-ft Melrose Park, Ill., biologics plant.

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September 30th, 2026

Teva's Denosumab-Adet (Degevma) Approved as Xgeva Biosimilar

Denosumab-adet now covers all 3 Xgeva indications, widening lower-cost treatment access for cancer patients with bone complications.

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September 29th, 2026

iRegene's NouvSight001 Cleared for US and China RP Trials

NouvSight001 isn't limited to the RPE65-mutation subset current gene therapy treats, potentially reaching more of the 1.5 million with RP worldwide.

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September 28th, 2026

Daiichi Sankyo, Merck Pull Ifinatamab Deruxtecan BLA in SCLC

Daiichi Sankyo and Merck pulled ifinatamab deruxtecan's FDA filing in small cell lung cancer after a 187-patient trial fell short.

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September 28th, 2026

FDA Approves Lilly's Insulin Efsitora Alfa-Gobe (Onswik) for Type 2 Diabetes

Insulin efsitora alfa-gobe (Onswik) cuts injections from 365 to 52 a year for adults with type 2 diabetes, per its new FDA approval.

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September 24th, 2026

FDA Grants SOTIO's SOT106 ADC Orphan Drug and Fast Track Designations for Sarcoma

SOTIO Biotech's LRRC15-targeted antibody-drug conjugate SOT106 now holds both Orphan Drug and Fast Track Designations in soft tissue sarcoma and osteosarcoma. The company expects to start first-in-human testing later in 2026.

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September 24th, 2026

Tecvayli-Darzalex Combo Shows Near-Normal Myeloma Survival

Johnson & Johnson's modeling projects 18.5-year life expectancy with Tecvayli-Darzalex versus 4.9 years for standard care.