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Novartis Gains EU Conditional Approval for Vijoice in Rare PIK3CA-Related Overgrowth Disorder PROS
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Ionetix Gains First ANDA Approval for Ga-68 Gozetotide, Expanding Multi-Site PET Network

Pharma Now Editorial Team

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Novartis Gains EU Conditional Approval for Vijoice in Rare PIK3CA-Related Overgrowth Disorder PROS

EMA recommends conditional EU approval for Novartis's Vijoice in PROS, imposing post-marketing study and pharmacovigilance obligations.

Pharma Now Editorial Team

Pharma Now

Ionetix Gains First ANDA Approval for Ga-68 Gozetotide, Expanding Multi-Site PET Network

Ionetix becomes the first commercial manufacturer to gain FDA ANDA approval for Ga-68 gozetotide, with a three-hour expiry window driving multi-site GMP complexity.

Pharma Now Editorial Team

Pharma Now

60 Degrees Pharmaceuticals Achieves Early Enrollment Milestone in Tafenoquine Babesiosis Trial

60 Degrees Pharmaceuticals reports enrollment one month ahead of schedule in its tafenoquine babesiosis trial, targeting interim analysis by early July 2026.

Pharma Now Editorial Team

Pharma Now

Boehringer Ingelheim Gains China Approval for HERNEXEOS in Unresectable NSCLC

China's NMPA clears Boehringer Ingelheim's HERNEXEOS as monotherapy for unresectable, locally advanced or metastatic NSCLC in adults.

Pharma Now Editorial Team

Pharma Now