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United States Food and Drug Administration

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A representative image illustrating Teva Pharmaceutical Industries’ ecopipam program as the FDA grants Priority Review for the investigational pediatric Tourette syndrome treatment following positive Phase 3 relapse-prevention data.
Pharma & Biotech

Teva’s ecopipam reaches FDA Priority Review after positive Phase 3 Tourette data

FDA grants Priority Review to Teva’s ecopipam after Phase 3 data showed a 53% lower Tourette relapse risk. See what the 2027 decision could mean.

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A representative image illustrating Humacyte, Inc.’s ATEV hemodialysis access program as peer-reviewed Phase 3 V007 data strengthen the company’s planned FDA filing for a potential dialysis indication.
Medical Devices & Diagnostics

ATEV beats AV fistula in Phase 3 dialysis trial as Humacyte prepares FDA filing

Humacyte’s ATEV beats AV fistula in Phase 3 dialysis access testing as peer-reviewed V007 data strengthen its planned 2026 FDA filing.

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Genetix Biotherapeutics’ partnership with the National Football League Alumni Association highlights efforts to expand sickle cell disease awareness and improve understanding of gene therapy treatment options, including LYFGENIA. Representative image.
Pharma & Biotech

Genetix Biotherapeutics targets sickle cell treatment awareness with NFL Alumni partnership

Genetix Biotherapeutics and NFL Alumni are targeting the awareness and access gap that still limits sickle cell gene therapy adoption.

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Cytovance Biologics is expanding its biologics development model with standalone analytical services covering method development, validation, GMP testing and stability programs without requiring a manufacturing contract. Representative image.
Pharma & Biotech

Cytovance widens biologics development offering after cell line and perfusion expansions

Cytovance Biologics opens GMP and non-GMP analytical testing without manufacturing contracts, widening its biologics development model.

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A representative image illustrating BlossomHill Therapeutics’ BH-30643 lung cancer program as the FDA grants Fast Track designation for the investigational therapy targeting EGFR C797S-positive non-small cell lung cancer after resistance to third-generation EGFR inhibitors.
Pharma & Biotech

FDA Fast Track designation advances BH-30643 in C797S-positive lung cancer

BH-30643 gets FDA Fast Track status after early responses in C797S-positive lung cancer as BlossomHill expands the Phase 1/2 SOLARA trial.

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A representative image illustrating Immatics’ anzu-cel melanoma program as the company revises the SUPRAME Phase 3 statistical plan and targets a definitive progression-free survival readout in the first half of 2027.
Pharma & Biotech

Anzu-cel Phase 3 plan changes as slower melanoma events push Immatics to single 2027 analysis

Immatics reshapes anzu-cel’s Phase 3 trial after slower PFS events, targeting one definitive H1 2027 analysis and a larger survival dataset.

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A representative image illustrating Oncolytics Biotech’s pelareorep colorectal cancer research as FDA feedback outlines a potential accelerated approval path in second-line RAS-mutant, microsatellite-stable metastatic colorectal cancer.
Pharma & Biotech

Pelareorep gets clearer FDA path toward accelerated approval in RAS-mutant colorectal cancer

FDA feedback could let pelareorep move directly into a pivotal colorectal cancer expansion if randomized REO 033 data support accelerated approval.

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A representative image illustrating EyePoint, Inc.’s DURAVYU wet age-related macular degeneration program after the Phase 3 LUGANO trial missed its primary endpoint despite reducing supplemental treatment burden by 42%.
Pharma & Biotech

DURAVYU Phase 3 setback leaves EyePoint relying on second pivotal wet AMD trial

DURAVYU misses its Phase 3 wet AMD endpoint despite cutting treatment burden 42%. See why EyePoint’s upcoming LUCIA trial is now critical.

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A representative image illustrating UroGen Pharma’s UGN-103 bladder cancer program as the company submits its FDA application following a 77.8% complete response rate in the Phase 3 UTOPIA trial.
Pharma & Biotech

UroGen takes UGN-103 to FDA as non-surgical bladder cancer strategy expands

UroGen files UGN-103 with the FDA after a 77.8% Phase 3 complete response rate as its bladder cancer franchise gains commercial momentum.

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Capricor Therapeutics’ deramiocel remains under active FDA review after the regulator agreed to consider 24-month HOPE-3 data, with the company now focusing its Duchenne muscular dystrophy case on preservation of upper limb skeletal muscle function. Representative image.
Pharma & Biotech

Capricor plans deramiocel BLA amendment with 24-month HOPE-3 data

Capricor Therapeutics says the United States Food and Drug Administration (FDA) is willing to review an amendment containing 24-month HOPE-3 data for deramiocel, keeping the experimental Duchenne muscular dystrophy cell therapy under active consideration despite a strongly negative advisory committee vote. The company intends to narrow the regulatory case from Duchenne-associated cardiomyopathy to preservation of

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