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Results For "US-FDA"

451 News Found

FDA expands use of Merck’s CAPVAXIVE for high-risk children and teens
Drug Approval | June 21, 2026

FDA expands use of Merck’s CAPVAXIVE for high-risk children and teens

The expanded approval covers children and teens with chronic conditions that increase vulnerability to pneumococcal infections


AbbVie's Allergan wins FDA nod for first injectable targeting neck lines
Drug Approval | June 18, 2026

AbbVie's Allergan wins FDA nod for first injectable targeting neck lines

The newly approved treatment, SKINVIVE by JUVÉDERM, is now the first and only hyaluronic acid injectable cleared specifically for improving neck appearance


Roche wins FDA approval for first PTEN-loss companion diagnostic in prostate cancer
News | June 16, 2026

Roche wins FDA approval for first PTEN-loss companion diagnostic in prostate cancer

The FDA nod marks a step forward in precision oncology, linking molecular diagnostics more tightly to therapy selection for advanced prostate cancer


Ryvu advances romaciclib program as FDA clears AML trial expansion
Clinical Trials | June 13, 2026

Ryvu advances romaciclib program as FDA clears AML trial expansion

The regulatory decision follows promising results from RIVER-81


GSK bets big on oncology with $10.6 billion Nuvalent acquisition
News | June 10, 2026

GSK bets big on oncology with $10.6 billion Nuvalent acquisition

Deal brings late-stage lung cancer candidates zidesamtinib and neladalkib into GSK’s portfolio


Pharma industry poised to reach US$ 130 billion by 2030: Joint Secretary, Department of Commerce
Policy | June 10, 2026

Pharma industry poised to reach US$ 130 billion by 2030: Joint Secretary, Department of Commerce

Mohit Yadav reaffirmed government's commitment to improve competitiveness, enhance export capabilities and support the country's transition from volume-driven to value-driven exports


Axplora consolidates global UDCA manufacturing at Vizag facility
News | June 10, 2026

Axplora consolidates global UDCA manufacturing at Vizag facility

Strategic shift from Italy to India strengthens supply chain resilience, expands capacity and enhances sustainability for the growing global UDCA market


FDA expands Pfizer’s HYMPAVZI approval
Drug Approval | June 09, 2026

FDA expands Pfizer’s HYMPAVZI approval

Broadening access for children & patients with inhibitor-complicated hemophilia


India’s medical devices sector is poised for a pharma-like transformation:  Pranav Sharma, SBU Head - Advanced Surgery, Healthium MedTech
interviews | June 03, 2026

India’s medical devices sector is poised for a pharma-like transformation: Pranav Sharma, SBU Head - Advanced Surgery, Healthium MedTech

The industry is expected to grow significantly over the next few years as healthcare accessibility improves and insurance penetration increases


FDA fast-tracks Roche’s giredestrant review as data signal potential shift in early breast cancer care
Drug Approval | June 03, 2026

FDA fast-tracks Roche’s giredestrant review as data signal potential shift in early breast cancer care

The filing is backed by Phase III data from the lidERA Breast Cancer study