Regulatory

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 (...

The US FDA Approves the Label Update of Gilead’s Biktarvy for Pregnant Adults with HIV

The US FDA Approves the Label Update of Gilead’s Biktarvy for Pregnant Adults with HIV

Shots: The US FDA approved label update with additional safety & efficacy data...

Pfizer’s BEQVEZ (fidanacogene elaparvovec-dzkt) Receives US FDA Approval for Adults with Hemophilia B

Pfizer’s BEQVEZ (fidanacogene elaparvovec-dzkt) Receives US FDA Approval for Adults with Hemophilia B

Shots: US FDA granted approval to Pfizer’s BEQVEZ, based on

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