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FDA approves Novartis Pluvicto for earlier treatment of PSMA-positive metastatic prostate cancer, expanding radioligand therapy into first-line care. Representative image.
Pharma & Biotech

FDA approves Novartis Pluvicto for earlier treatment of PSMA-positive metastatic prostate cancer

The United States Food and Drug Administration (FDA) has approved Novartis Pharmaceuticals Corporation’s Pluvicto in combination with androgen receptor pathway inhibitor therapy for adults with prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer, moving targeted radioligand therapy into an earlier stage of the disease. The July 31 approval covers patients whose metastatic cancer remains responsive

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FDA advisers back Replimune Group’s RP1 plus nivolumab for advanced melanoma after two regulatory rejections, reviving the oncolytic virus therapy’s approval prospects. Representative image.
Pharma & Biotech

FDA panel supports Replimune’s RP1 melanoma data after two regulatory rejections

A United States Food and Drug Administration (FDA) advisory committee has voted 10 to 3 that efficacy findings from Replimune Group’s IGNYTE study of RP1 plus nivolumab are evaluable and clinically meaningful, handing the experimental melanoma treatment a significant regulatory reprieve after two earlier rejection letters. The committee considered RP1, also known as vusolimogene oderparepvec,

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Representative image: A precision-medicine laboratory setting reflects Teverelix’s UAE Phase 2a study, which combines estradiol suppression with genomic profiling to explore more personalized treatment insights.
Pharma & Biotech

UAE authorizes PRECISION-E2 trial of Teverelix for symptomatic endometriosis

UAE authorizes the PRECISION-E2 trial of Teverelix, combining estradiol suppression, symptom tracking and genomic analysis in endometriosis

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Representative image: Hematology researchers analyze blood samples as Moleculin’s $MBRX MIRACLE trial reports a 37% blinded composite remission rate in relapsed or refractory acute myeloid leukemia, including patients who previously failed venetoclax.
Pharma & Biotech

New MIRACLE data examine remission after venetoclax failure in relapsed AML

MIRACLE reports a 37% blinded composite remission rate in relapsed AML, including patients who previously failed venetoclax treatment.

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Representative image: Cardiovascular researchers review heart imaging and trial data as Novo Nordisk’s $NVO ziltivekimab lowers inflammation but fails to reduce heart attacks, strokes or cardiovascular deaths in the Phase 3 ZEUS trial.
Pharma & Biotech

Ziltivekimab lowers inflammation but fails Phase 3 cardiovascular outcomes test

Ziltivekimab lowered IL-6 activity and hsCRP but failed to reduce major cardiovascular events in Novo Nordisk’s 6,300-patient ZEUS trial.

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PVP Labs’ investigational Taphalgin pain therapy is being evaluated as a potential battlefield and military surgical-care option, with clinical evidence set for presentation at MHSRS 2026. Representative image.
Pharma & Biotech

Can PVP Labs turn Taphalgin into a battlefield alternative to scheduled opioids?

PVP Labs will present Taphalgin at MHSRS 2026 as a battlefield pain candidate, but U.S. trials and FDA review remain decisive.

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miRecule and Rio Biofarma are combining peptide delivery technology with RNA therapeutics to pursue targeted drug delivery beyond the liver, although clinical validation remains ahead. Representative image.
Pharma & Biotech

How miRecule’s Rio Biofarma partnership could advance extrahepatic RNA delivery

miRecule and Rio Biofarma are pairing peptide delivery with RNA payloads, but clinical validation and scalable manufacturing remain ahead.

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Fresenius Kabi’s PB016 vedolizumab biosimilar has entered FDA and EMA review, advancing a potential Entyvio competitor for ulcerative colitis and Crohn’s disease. Representative image.
Pharma & Biotech

What Fresenius Kabi’s PB016 regulatory filings mean for the Entyvio biosimilar market

Fresenius advances PB016 into FDA and EMA review, but competition, manufacturing scrutiny and IV-only positioning will shape its launch path.

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Researchers assess clinical data and overlooked drug-development opportunities as Lōkahi Therapeutics expands its ai² Futures Lab to build a capital-efficient biopharma pipeline. Representative image.
Pharma & Biotech

Glucotrack expands Lōkahi Therapeutics ai² Futures Lab to 12 universities

Lōkahi Therapeutics screened 45-plus drug assets for $33,000. Can its university model turn overlooked programs into pipeline deals?

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Meitheal Pharmaceuticals’ FDA approval of Garzulys insulin aspart-fsan adds a new biosimilar option to the U.S. rapid-acting insulin market, sharpening competition around pricing, patient access and reliable supply. Representative image.
Pharma & Biotech

Meitheal has FDA approval for Garzulys, but can it break into America’s crowded mealtime insulin market?

FDA approval moves Meitheal’s Garzulys into the U.S. insulin aspart market, where pricing, supply and formulary access will decide uptake.

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