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United States Food and Drug Administration

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Teva Pharmaceutical Industries’ once-monthly TEV-’749 could make long-acting olanzapine more practical if FDA review supports use without the three-hour post-injection monitoring required for existing olanzapine depot therapy. Representative image.
Features & Analysis

Teva saw no PDSS across 3,470 injections. Could TEV-’749 finally make long-acting olanzapine practical?

Teva Pharmaceutical Industries has reported new long-term data for once-monthly subcutaneous TEV-’749 ahead of an expected fourth-quarter FDA decision. Its competitive proposition is not a new antipsychotic mechanism, but an attempt to combine established olanzapine efficacy with long-acting dosing without the post-injection monitoring burden that has constrained the existing olanzapine depot.

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Xenon Pharmaceuticals has submitted azetukalner for FDA approval in focal seizures while separately evaluating neuropsychiatric adverse events in its depression programmes. Representative image.
Features & Analysis

Azetukalner’s epilepsy NDA is backed by 1,500 patient-years. Do psychiatric adverse events change the regulatory equation?

Xenon Pharmaceuticals has submitted azetukalner for FDA approval in focal seizures after strong Phase 3 efficacy and more than 1,500 patient-years of epilepsy exposure. On the same day, the company paused new enrollment in psychiatry studies after neuropsychiatric adverse events emerged, creating a difficult question over how regulators and investors should interpret safety signals that

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Ultragenyx Pharmaceutical’s $3.95 million FAYUVI gene therapy is the first FDA-approved disease-modifying treatment for children with Sanfilippo syndrome type A. Representative image.
Features & Analysis

FAYUVI costs $3.95m for one infusion. Can Ultragenyx make the first Sanfilippo therapy accessible?

Ultragenyx Pharmaceutical has won FDA approval for FAYUVI, the first treatment designed to alter the course of Sanfilippo syndrome type A. The one-time AAV9 gene therapy carries a $3.95 million U.S. list price and will initially flow through specialist treatment centres, putting early diagnosis, payer access and preservation of neurodevelopmental function at the centre of

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Medical Devices & Diagnostics

FDA 510(k) clearance gives CurveBeam AI first step toward CT bone-health SaaS

FDA clears CurveBeam AI’s BoneVue CT bone-density technology, while a second HiRise clearance remains necessary for its planned BMD SaaS launch.

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Medical Devices & Diagnostics

FDA cleared Beta Bionics’ Mint patch pump. Why did BBNX immediately sell $150m of stock?

Beta Bionics wins FDA clearance for Mint, targets a Q1 2027 launch and prices a $150 million offering to support commercialization.

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Pharma & Biotech

Cogent Biosciences now has three bezuclastinib NDAs under FDA review

Cogent now has three bezuclastinib NDAs under FDA review, with GIST and non-advanced mastocytosis decisions due before year-end.

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Pharma & Biotech

Biohaven stock remains under pressure after FDA partial hold on opakalim epilepsy program

Biohaven’s opakalim program faces an FDA partial hold over a rodent metabolite, while a fully enrolled pivotal epilepsy study remains on track.

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Pharma & Biotech

IOVA has climbed more than 400% from its low. Can lung cancer turn Amtagvi into a much bigger franchise?

Iovance approaches new lung cancer data as Amtagvi revenue hits $91 million and IOVA trades near a 52-week high after a major 2026 rally.

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Pharma & Biotech

Rocket Pharmaceuticals gets FDA path to complete RP-A501 Danon disease pivotal trial

FDA clears Rocket Pharmaceuticals to continue its recalibrated RP-A501 pivotal trial, restoring a defined accelerated approval path in Danon disease.

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Pharma & Biotech

TRUTAKNA cut kidney progression risk 76%. Why did VERA stock give up a double-digit rally?

TRUTAKNA cuts IgA nephropathy progression risk 76% through two years, but VERA stock reverses as competition and launch execution come into focus.

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