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United States Food and Drug Administration

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Pfizer’s positive Phase 3 LITFULO results in nonsegmental vitiligo have strengthened the treatment’s global regulatory prospects, while detailed efficacy, safety and durability data remain key to its clinical and commercial outlook. Representative image.
Pharma & Biotech

Pfizer’s LITFULO cleared a major Phase 3 hurdle in vitiligo, but the missing numbers could decide its future

Pfizer’s Phase 3 LITFULO vitiligo results strengthen its filing case, but dose, safety and durability details remain decisive.

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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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Median Technologies and Olea Medical are partnering to expand commercial deployment of eyonis LCS, an artificial intelligence-assisted lung cancer screening platform designed to support radiologists reviewing low-dose chest computed tomography scans. Representative image.
Medical Devices & Diagnostics

Can Canon Medical’s imaging reach turn eyonis LCS regulatory success into hospital adoption?

Median Technologies and Olea Medical will deploy eyonis LCS across United States and European lung cancer screening workflows.

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RecovryAI is evaluating its clinical AI Virtual Care Assistant for monitoring patients after hip and knee replacement surgery as it prepares for a planned FDA De Novo filing. Representative image.
Medical Devices & Diagnostics

Can RecovryAI’s Virtual Care Assistant secure FDA De Novo authorization?

RecovryAI completes a 525-patient pivotal study phase as it prepares an FDA De Novo filing for postoperative clinical AI.

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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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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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Polpharma Biologics’ PB016 vedolizumab biosimilar has entered regulatory review with the United States Food and Drug Administration and European Medicines Agency, advancing a potential new competitor to Takeda Pharmaceutical Company’s Entyvio for ulcerative colitis and Crohn’s disease. Representative image.
Pharma & Biotech

PB016 versus Entyvio: Polpharma Biologics joins the emerging vedolizumab biosimilar race

Polpharma Biologics’ PB016 enters FDA and EMA review, adding a new vedolizumab biosimilar challenge to Takeda’s Entyvio franchise.

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Representative image: Clinicians review heart imaging and Duchenne muscular dystrophy trial data as Capricor Therapeutics’ $CAPR deramiocel faces heightened FDA uncertainty following a 9 to 3 advisory committee vote against its cardiomyopathy evidence.
Pharma & Biotech

Conflicting HOPE-3 analyses divide FDA panel over deramiocel in Duchenne muscular dystrophy

FDA advisers voted 9 to 3 against deramiocel’s Duchenne cardiomyopathy evidence after challenging the Phase 3 analysis and trial population.

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Representative image: Researchers examine brain imaging and neural cell preparations as Hopstem’s hNPC01 receives FDA clearance for clinical trials targeting chronic motor disability after hemorrhagic stroke and traumatic brain injury.
Pharma & Biotech

FDA clears hNPC01 neural cell therapy trials for hemorrhagic stroke and traumatic brain injury

FDA clears Hopstem’s hNPC01 neural cell therapy for trials in hemorrhagic stroke and traumatic brain injury, with Fast Track status in both.

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Representative image: Clinicians prepare a donor-derived cell therapy infusion as TScan Therapeutics’ $TCRX TSC-101 enters the Phase 3 ALLOHA-2 trial to prevent AML and MDS relapse after stem cell transplantation.
Pharma & Biotech

TSC-101 enters pivotal ALLOHA-2 trial after early donor-chimerism results

TSC-101 enters the Phase 3 ALLOHA-2 trial to test whether donor-derived TCR-T therapy can prevent AML and MDS relapse after transplant.

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