Regulatory

Biotheryx Receives the US FDA’s IND Approval of BTX-9341 for Treating Breast Cancer

Biotheryx Receives the US FDA’s IND Approval of BTX-9341 for Treating Breast Cancer

Shots: The US FDA has cleared the IND application of the company’s BTX-9341...

Innovent’s IBI343 a Monotherapy Receives the NMPA’s Breakthrough Therapy Designation for Advanced Gastric Cancer (GC)

Innovent’s IBI343 a Monotherapy Receives the NMPA’s Breakthrough Therapy Designation for Advanced Gastric Cancer (GC)

Shots: The NMPA has granted BTD to IBI343 as monotx. for the treatment of advanced...

BMS Reports the US FDA’s Acceptance of BLA for Opdivo to Treat Clear Cell Renal Cell Carcinoma

BMS Reports the US FDA’s Acceptance of BLA for Opdivo to Treat Clear Cell Renal Cell Carcinoma

Shots: The US FDA has accepted the BLA of SC Opdivo co-formulated with Halozyme&rs...

IRLAB Therapeutics Gains the Swedish Medical Products Agency’s Approval to Initiate P-I Trial of IRL757 for Apathy

IRLAB Therapeutics Gains the Swedish Medical Products Agency’s Approval to Initiate P-I Trial of IRL757 for Apathy

Shots: The P-I trial (to be funded by The Michael J. Fox Foundation for Parkinson&...

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...

Image