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Results For "approval"

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Ascendis Pharma’s FDA review of Achondroplasia drug gets 3-month delay
Drug Approval | November 30, 2025

Ascendis Pharma’s FDA review of Achondroplasia drug gets 3-month delay

The FDA has classified recent submissions as a major amendment pushing the approval to its NDA for TransCon CNP back three months to February 28, 2026


MHRA clears inavolisib, offering new option for returning breast cancer
News | November 30, 2025

MHRA clears inavolisib, offering new option for returning breast cancer

The oral, film-coated tablet is licensed for patients whose cancer has returned during or shortly after hormone therapy


Piramal Pharma Solutions achieves global nitrosamine compliance, strengthening patient safety
News | November 28, 2025

Piramal Pharma Solutions achieves global nitrosamine compliance, strengthening patient safety

Nitrosamines have prompted evolving global guidelines that demand rigorous industry oversight


Cidara hits target enrollment for Phase 3 flu trial ahead of peak season
Clinical Trials | November 27, 2025

Cidara hits target enrollment for Phase 3 flu trial ahead of peak season

CD388 is administered as a single 450-milligram subcutaneous dose in adults and adolescents


EU greenlights Dupixent for chronic urticaria, offering new hope to patients
Drug Approval | November 27, 2025

EU greenlights Dupixent for chronic urticaria, offering new hope to patients

It's a development that marks a major step forward for patients struggling with moderate-to-severe chronic spontaneous urticaria


NHS’s breakthrough leukaemia therapy set to transform lives in UK
Clinical Trials | November 27, 2025

NHS’s breakthrough leukaemia therapy set to transform lives in UK

Clinical trials found that 77% of patients went into remission after receiving obe-cel


India becomes first country to approve STIMULAN Rapid Cure with antifungals
Medical Device | November 26, 2025

India becomes first country to approve STIMULAN Rapid Cure with antifungals

Surgical site infections and antimicrobial resistance remain major challenges globally


Novartis scores FDA nod for game-changing SMA treatment
Biotech | November 26, 2025

Novartis scores FDA nod for game-changing SMA treatment

Itvisma is a one-time, fixed-dose therapy designed to tackle the genetic root cause of SMA


Gilead delivers groundbreaking HIV prevention drug to Eswatini & Zambia
Biopharma | November 25, 2025

Gilead delivers groundbreaking HIV prevention drug to Eswatini & Zambia

The deliveries bring the innovative medicine to communities heavily impacted by HIV just five months after U.S. FDA approval