Business, energy, technology, markets and global industry news from Business News Today

FDA approval

Pharma & Biotech

Citius Oncology raises $36.5m, but can Lymphir convert rare cancer approval into commercial traction?

Lymphir has funding and FDA approval. Citius Oncology now faces the harder test of turning rare cancer access into real adoption.

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Medical Devices & Diagnostics

SOLVD Health broadens AvertD access as FDA clears blood-based sample collection

FDA cleared blood-based collection for SOLVD Health’s AvertD. Find out why this could expand genetic opioid risk testing in surgical care.

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Pharma & Biotech

How Agilent’s PD-L1 companion diagnostic now shapes pembrolizumab access in esophageal carcinoma

FDA approves Agilent's PD-L1 IHC 22C3 pharmDx for esophageal and GEJ carcinoma, marking the eighth companion diagnostic indication alongside pembrolizumab. Read the analysis.

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Pharma & Biotech

How Galderma is repositioning Restylane Contour beyond cheeks into full-face structural correction

FDA approval of Restylane Contour for temple hollowing signals a shift in facial aesthetics. Discover what this means for the industry and future treatments.

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Medical Devices & Diagnostics

LivaNova PLC expands sleep apnea eligibility as aura6000 gains FDA approval without CCC limits

LivaNova PLC secures FDA approval for aura6000. Discover how it could reshape sleep apnea treatment and expand patient eligibility.

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Pharma & Biotech

How Bristol Myers Squibb’s Opdivo approvals in frontline and relapsed classical Hodgkin lymphoma reset treatment pathways

Nivolumab wins U.S. frontline and EU relapsed cHL approvals. Analyse what the dual verdict means for sequencing, safety, and reimbursement.

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Pharma & Biotech

J&J’s Tecvayli-Darzalex Faspro combination approved for myeloma after MajesTEC-3 Phase 3 results

FDA approves J&J's teclistamab plus daratumumab for relapsed myeloma from second line. Analyse the MajesTEC-3 data, safety profile, and what this changes for treatment.

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Pharma & Biotech

Can Acadia overturn EMA’s negative opinion on trofinetide for Rett syndrome?

Acadia seeks EU re-examination after CHMP rejects trofinetide for Rett syndrome. Read the regulatory and clinical implications.

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Medical Devices & Diagnostics

Organon & Co. strengthens LARC strategy with MIUDELLA license from Sebela Pharmaceuticals

Organon & Co. licenses MIUDELLA copper IUD. Explore what this means for hormone-free contraception and LARC competition. Read the analysis.

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Pharma & Biotech

Eton Pharmaceuticals expands rare endocrine portfolio with FDA-backed liquid desmopressin

FDA approves DESMODA oral solution for central diabetes insipidus. Explore what this means for dosing precision and rare endocrine care.

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