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Representative image: Retinal imaging illustrates geographic atrophy as Ocugen advances OCU410 into Phase 3 testing as a potential one-time gene therapy for dry age-related macular degeneration.
Pharma & Biotech

One-time OCU410 gene therapy enters Phase 3 as Ocugen targets geographic atrophy treatment burden

Ocugen starts Phase 3 testing of one-time OCU410 gene therapy after a 31% reduction in geographic atrophy lesion growth in Phase 2.

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Representative image: Injectable inflammatory bowel disease treatment devices illustrate Alvotech’s AVT80 program as the FDA reviews its proposed interchangeable subcutaneous Entyvio biosimilar for ulcerative colitis and Crohn’s disease.
Pharma & Biotech

Alvotech advances dual Entyvio biosimilar strategy as FDA accepts subcutaneous AVT80 application

FDA accepts Alvotech’s AVT80 application for a subcutaneous Entyvio biosimilar, expanding its vedolizumab strategy alongside Teva.

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Representative image: Laboratory blood analysis illustrating Cadrenal Therapeutics’ CAD-1005 program as the company gains FDA alignment for a Phase 3 trial targeting thromboembolic complications in heparin-induced thrombocytopenia.
Pharma & Biotech

CAD-1005 moves toward Phase 3 as FDA backs thrombotic endpoint strategy in heparin-induced thrombocytopenia

Cadrenal Therapeutics gains FDA alignment on a Phase 3 CAD-1005 trial in HIT after encouraging thrombosis data. See the risks and next steps.

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Representative image: Oral preventive therapy for hereditary angioedema as BioCryst Pharmaceuticals expands ORLADEYO into younger children in Japan, strengthening the drug’s global pediatric HAE growth opportunity.
Pharma & Biotech

Japan approves pediatric ORLADEYO as BioCryst Pharmaceuticals expands hereditary angioedema reach

Japan expands ORLADEYO to children aged 2 to under 12 as BioCryst Pharmaceuticals builds its global HAE franchise. See what comes next.

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Scholar Rock has preserved apitegromab’s September 30 FDA target date by removing the OAI-classified Catalent Indiana facility from its US filing and shifting to an alternate manufacturer, while preparing to resubmit the European application. Representative image.
Pharma & Biotech

One fill-finish plant exits, another takes over as Scholar Rock keeps apitegromab on track for FDA review

Scholar Rock has removed the OAI-classified Catalent Indiana facility from apitegromab’s US filing, preserving its September 30 FDA target through an alternate manufacturer while withdrawing and preparing to resubmit the European application.

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A representative image illustrating Johnson & Johnson’s TECVAYLI plus daratumumab multiple myeloma combination as European approval follows Phase 3 data showing an 83.4% reduction in the risk of disease progression or death.
Pharma & Biotech

TECVAYLI-daratumumab wins EU approval after cutting myeloma progression risk 83%

EU approval moves TECVAYLI plus daratumumab into earlier multiple myeloma treatment after Phase 3 data cut progression risk by 83.4%.

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A representative image illustrating Regeneron Pharmaceuticals’ Pasatru approval as the FDA clears the new fibrodysplasia ossificans progressiva treatment after Phase 3 data showed a 90% reduction in new heterotopic ossification lesions.
Pharma & Biotech

FDA clears monthly Pasatru after Phase 3 data show sharp drop in abnormal bone formation

FDA approves Regeneron’s Pasatru after Phase 3 data showed a 90% reduction in new FOP bone lesions. See what the new therapy means.

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A representative image illustrating NervGen Pharma’s NVG-291 spinal cord injury program as the Phase 3 RESTORE trial prepares to test whether the therapy can improve hand function in adults living with chronic tetraplegia.
Pharma & Biotech

NervGen takes small but encouraging NVG-291 dataset into a pivotal chronic tetraplegia trial

NVG-291 Phase 3 screening starts in September as NervGen targets hand-function recovery in chronic tetraplegia. See what RESTORE must prove.

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A representative image illustrating Theriva Biologics’ VCN-01 retinoblastoma research as the company prepares a proposed Phase 2/3 study aimed at preserving the eye in children with treatment-resistant disease.
Pharma & Biotech

VCN-01 moves toward Phase 2/3 retinoblastoma trial after Theriva completes study design

Theriva designs a Phase 2/3 VCN-01 retinoblastoma trial after early eye-preservation signals. See what the planned FDA meeting could change.

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A representative image illustrating Hemab Therapeutics’ sutacimig research as the once-weekly therapy moves toward a pivotal Phase 3 trial after sustained reductions in bleeding among patients with Glanzmann thrombasthenia.
Pharma & Biotech

FDA endorsement moves once-weekly sutacimig into decisive Glanzmann thrombasthenia study

Sutacimig gets an FDA-backed Phase 3 path after sustained bleed reductions in Glanzmann thrombasthenia. Read what the pivotal trial must prove.

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