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Results For "regulatory-approval"

316 News Found

Gilead’s new HIV therapy shows promising Phase 3 results
Clinical Trials | December 19, 2025

Gilead’s new HIV therapy shows promising Phase 3 results

The study found BIC/LEN to be statistically non-inferior to BIKTARVY, Gilead’s current standard-of-care therapy


FDA completes inspection of SMS Pharma’s Vizag facility
Drug Approval | December 14, 2025

FDA completes inspection of SMS Pharma’s Vizag facility

The inspection concluded with one minor observation in Form 483


Lilly drug cuts risk of disease progression or death by 80% in trial
Clinical Trials | December 11, 2025

Lilly drug cuts risk of disease progression or death by 80% in trial

The company has unveiled the results of pirtobrutinib from its BRUIN CLL-313 study


Novo Nordisk completes acquisition of Akero Therapeutics
News | December 10, 2025

Novo Nordisk completes acquisition of Akero Therapeutics

Akero became a wholly owned subsidiary of Novo Nordisk


Lilly to invest $6 billion in Huntsville manufacturing hub
News | December 10, 2025

Lilly to invest $6 billion in Huntsville manufacturing hub

The new site will produce next-generation synthetic medicine active pharmaceutical ingredients


Capricor's cell therapy shows breakthrough results in Duchenne muscular dystrophy trial
Clinical Trials | December 09, 2025

Capricor's cell therapy shows breakthrough results in Duchenne muscular dystrophy trial

It's a development that marks a potential breakthrough for people living with the rare and debilitating disease Duchenne muscular dystrophy (DMD)


Jacobio combo delivers 71% ORR, sets stage for first SHP-2–based NSCLC therapy
Clinical Trials | December 04, 2025

Jacobio combo delivers 71% ORR, sets stage for first SHP-2–based NSCLC therapy

Jacobio stated that these findings underscore the potential of glecirasib and sitneprotafib


Aelis Farma gets EMA nod for phase 2B trial of AEF0217 in down syndrome
Biopharma | December 04, 2025

Aelis Farma gets EMA nod for phase 2B trial of AEF0217 in down syndrome

AEF0217 is a first-in-class CB1 receptor signaling-specific inhibitor


WHO urges rapid expansion of new HIV prevention tools amid funding crisis
Healthcare | December 03, 2025

WHO urges rapid expansion of new HIV prevention tools amid funding crisis

Despite steep funding setbacks, the global HIV response has gained momentum in 2025 with the introduction of twice-yearly injectable LEN


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