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Pharma & Biotech

Pharma & Biotech

FDA removes CNS limitation for Yescarta, reshaping the regulatory boundary for CAR T therapy in primary CNS lymphoma

Kite Pharma, a subsidiary of Gilead Sciences, has received approval from the U.S. Food and Drug Administration to update the prescribing information for Yescarta axicabtagene ciloleucel by removing the prior limitation of use in patients with relapsed or refractory primary central nervous system lymphoma. The decision follows safety findings from an investigator sponsored Phase 1

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Pharma & Biotech

Genentech’s fenebrutinib challenges the PPMS treatment ceiling but does not yet reset it

Genentech has reported late-breaking Phase III data from the FENtrepid trial showing that its investigational Bruton’s tyrosine kinase inhibitor fenebrutinib achieved non-inferiority to ocrelizumab in reducing disability progression in patients with primary progressive multiple sclerosis. The results were presented at the ACTRIMS Forum 2026 and position fenebrutinib as the first oral, brain-penetrant therapy to directly

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Pharma & Biotech

What TG Therapeutics’ ACTRIMS strategy signals about the next competitive phase in anti-CD20 multiple sclerosis therapy

Find out how TG Therapeutics’ ACTRIMS strategy reshapes competition in anti-CD20 multiple sclerosis therapy and what clinicians and regulators are watching next.

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Pharma & Biotech

Clearmind Medicine Inc. and Polyrizon Ltd. target formulation risk in MEAI’s addiction program

Discover how Clearmind Medicine Inc.’s intranasal MEAI strategy could reshape CNS drug delivery and clinical outcomes. Read the analysis.

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Pharma & Biotech

What Johnson & Johnson’s AKEEGA opinion means for PARP inhibitors beyond castration resistance

Find out how Johnson & Johnson’s CHMP opinion for AKEEGA could shift prostate cancer treatment toward earlier, biomarker-guided precision therapy.

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Pharma & Biotech

Can Idorsia Pharmaceuticals Ltd’s lucerastat redefine Fabry disease treatment beyond enzyme replacement therapy?

Discover how Idorsia Pharmaceuticals Ltd’s FDA-aligned Phase 3 plan could make lucerastat the first oral therapy for all Fabry disease patients. Read the analysis.

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Pharma & Biotech

Why Pulmovant’s PHocus study design matters for regulatory confidence in pulmonary hypertension associated with interstitial lung disease

Pulmovant completes PHocus enrollment for mosliciguat in PH-ILD. Find out what this milestone really means ahead of 2026 clinical data.

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Pharma & Biotech

How Priovant’s brepocitinib advances a long-overlooked inflammatory skin disease toward approval

Strong Phase 2 data put brepocitinib on a rare pivotal path in cutaneous sarcoidosis. Find out what this changes for clinicians and regulators.

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Pharma & Biotech

Can Ampligen plus durvalumab finally overcome immunotherapy resistance in metastatic pancreatic cancer

Explore what AIM ImmunoTech’s Ampligen Phase 2 data could change for pancreatic cancer immunotherapy and what risks still remain.

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Pharma & Biotech

What Propanc Biopharma’s PRP signals about alternative mechanisms in the crowded pancreatic cancer pipeline

Can PRP’s proenzyme approach change pancreatic cancer treatment strategy? Explore what Propanc Biopharma’s data means for oncology innovation.

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