Regulatory

Amolyt Pharma’s Eneboparatide Receives the US FDA’s Fast Track Designation for Hypoparathyroidism

Amolyt Pharma’s Eneboparatide Receives the US FDA’s Fast Track Designation for Hypoparathyroidism

Shots: The US FDA has granted fast track designation to the company’s enebop...

Taysha Gene Therapies’ TSHA-102 Receives the US FDA’s Regenerative Medicine Advanced Therapy Designation for Rett Syndrome

Taysha Gene Therapies’ TSHA-102 Receives the US FDA’s Regenerative Medicine Advanced Therapy Designation for Rett Syndrome

Shots: The US FDA granted RMAT designation to TSHA-102 based on safety & effic...

X4 Pharmaceuticals’ Xolremdi Receives the US FDA’s Approval for the Treatment of WHIM Syndrome

X4 Pharmaceuticals’ Xolremdi Receives the US FDA’s Approval for the Treatment of WHIM Syndrome

Shots: The US FDA has approved Xolremdi (mavorixafor) capsules for treating WHIM s...

Johnson & Johnson’s Sirturo Gains the CHMP’s Positive Opinion to Treat Multidrug-Resistant Tuberculosis

Johnson & Johnson’s Sirturo Gains the CHMP’s Positive Opinion to Treat Multidrug-Resistant Tuberculosis

Shots: The CHMP has granted positive opinion to the company’s Sirturo (bedaq...

AstraZeneca’s Truqap Plus Faslodex Receives the CHMP’s Positive Opinion for Treating Breast Cancer

AstraZeneca’s Truqap Plus Faslodex Receives the CHMP’s Positive Opinion for Treating Breast Cancer

Shots: The CHMP's positive opinion was based on the P-III (

Takeda’s Fruquintinib Gains the CHMP’s Positive Opinion for Previously Treated Metastatic Colorectal Cancer

Takeda’s Fruquintinib Gains the CHMP’s Positive Opinion for Previously Treated Metastatic Colorectal Cancer

Shots: The CHMP has granted positive opinion to the company’s fruquintinib (...

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