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Genentech’s Gazyva enters FDA Priority Review for primary membranous nephropathy following the Phase III MAJESTY remission results. Representative image.
Pharma & Biotech

FDA gives Genentech’s Gazyva Priority Review for primary membranous nephropathy

FDA Priority Review puts Genentech’s Gazyva on a November decision path in primary membranous nephropathy after the Phase III MAJESTY win.

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Niagen Bioscience’s NB4168 has secured U.S. FDA Rare Pediatric Disease and European orphan designations as the company advances the experimental ataxia telangiectasia therapy toward human trials. Representative image.
Pharma & Biotech

Niagen wins twin rare-disease designations, but can NB4168 turn nicotinamide riboside evidence into a medicine?

Niagen Bioscience gains U.S. and EU rare-disease designations for NB4168, but human trials and proof of efficacy still lie ahead.

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Pharma & Biotech

MaaT Pharma AGM strengthens funding authority as MaaT013 faces September regulatory test

MaaT Pharma shareholders have preserved the biotechnology firm’s ability to raise capital as MaaT013 enters a decisive regulatory re-examination and its operating cash runway narrows.

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Representative image: Omeros Corporation faces a crucial European regulatory test after the CHMP rejected narsoplimab for TA-TMA, raising fresh questions over clinical evidence, trial design and the therapy’s path to approval.
Pharma & Biotech

Omeros’ TA-TMA therapy hits European hurdle as regulators question treatment effect

Omeros faces a CHMP refusal for narsoplimab in TA-TMA. Read what the EU re-examination means for evidence, access and launch plans.

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Incyte’s Opzelura wins positive CHMP opinion for moderate atopic dermatitis in Europe
Pharma & Biotech

Incyte’s Opzelura wins positive CHMP opinion for moderate atopic dermatitis in Europe

The positive opinion moves ruxolitinib cream closer to a broader European label for adults inadequately controlled by standard topical therapies, opening a potential treatment position between conventional creams and systemic medicines.

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CHMP backs Datroway in first-line TNBC
Pharma & Biotech

Datroway nears EU first-line approval for metastatic triple-negative breast cancer

Discover how Datroway’s EU recommendation could reshape first-line treatment for metastatic triple-negative breast cancer. Read the analysis.

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A clinician discusses Rett syndrome care with a patient and caregiver as Daybu moves closer to European approval following a positive CHMP recommendation. Representative image.
Pharma & Biotech

Acadia Pharmaceuticals secures positive CHMP opinion for Daybu in narrowed Rett syndrome indication

Discover why Daybu’s CHMP turnaround could reshape Rett syndrome treatment in Europe and what clinical and access hurdles remain.

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A clinician reviews an investigational treatment as MaaT Pharma prepares to challenge the negative European regulatory opinion on MaaT013 for acute graft-versus-host disease. Representative image.
Pharma & Biotech

MaaT Pharma seeks second review of MaaT013 as regulators question single-arm evidence

Discover why MaaT Pharma is challenging the negative CHMP opinion on MaaT013 and what the September review means for acute graft-versus-host disease.

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Pharma & Biotech

Why Praxis’ latest FDA win could matter far beyond one genetic epilepsy program

Find out how Praxis’ FDA Breakthrough Therapy Designation for elsunersen could reshape SCN2A-DEE epilepsy treatment and ASO development.

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Pharma & Biotech

Regeneron’s cemdisiran enters FDA and EMA review for generalized myasthenia gravis

Find out how Regeneron’s cemdisiran review could reshape generalized myasthenia gravis care with potential quarterly subcutaneous dosing.

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