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

United States Food and Drug Administration

Pharma & Biotech

Can Lupin Limited gain ground in cardiometabolic generics with United States dapagliflozin launch?

Lupin Limited has launched generic dapagliflozin in the United States. Read what it means for Farxiga, pricing pressure, and market access.

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Pharma & Biotech

Eli Lilly and Company’s Foundayo approval could widen the obesity market faster than rivals expected

Eli Lilly and Company’s Foundayo approval could reshape obesity treatment. Read what the oral GLP-1 launch changes for clinicians, payers, and rivals.

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Pharma & Biotech

Lupin Limited moves closer to the Wakix market as pitolisant tentative approval sharpens future optionality

Lupin Limited has won tentative FDA approval for pitolisant tablets. Read why timing, exclusivity, and Wakix market dynamics matter next.

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Pharma & Biotech

What AEON Biopharma Inc.’s analytical strategy reveals about the future of botulinum toxin biosimilars

AEON Biopharma advances ABP-450 biosimilar strategy. Discover what this means for BOTOX competition and future complex biologics markets.

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Pharma & Biotech

Biofrontera targets U.S. label expansion for Ameluz in trunk and extremities

Phase 1 PK data bring Ameluz closer to broader FDA review. Explore the regulatory stakes and market impact in actinic keratosis.

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Pharma & Biotech

DifGen Pharmaceuticals expands complex generics footprint with fluorometholone ophthalmic suspension approval

DifGen Pharmaceuticals secures rare FDA approval for fluorometholone ophthalmic suspension. Find out why this complex generic matters for ophthalmology markets.

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Pharma & Biotech

MAIA Biotechnology advances ateganosine cancer program with Phase 3 THIO-104 trial and 2026 catalyst timeline

Find out how MAIA Biotechnology is advancing ateganosine into Phase 3 and why its 2026 clinical milestones could reshape treatment options in lung cancer.

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Features & Analysis

Is AI finally ready to close the equity gap in breast cancer screening in the United States and beyond?

The rapid progress of artificial intelligence in medical imaging is creating fresh optimism among healthcare leaders seeking to close the persistent equity gap in breast cancer screening. The regulatory push by Lunit, a Seoul-based AI diagnostics firm, for its Lunit INSIGHT Risk model, which estimates a woman’s five-year breast cancer risk directly from mammogram images,

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