Shots: The BT designation is based on P-III INBUILD study results assessing OFEV vs PBO in patients with chronic fibrosing interstitial lung disease (ILDs) with signs of progression for 52 […]readmore
Tags : Breakthrough Therapy
Pharma
Regulatory
AstraZeneca’s Calquence (acalabrutinib) Receives the US FDA’s Breakthrough Therapy Designation
Shots: The FDA’s BT Designation is based on the P-III ELEVATE-TN assessing Calquence (100 mg, bid) as monothx or in combination with obinutuzumab vs chlorambucil + obinutuzumab and in 535 […]readmore
Pharma
Regulatory
AstraZeneca’s Selumetinib Receives the US FDA’s Breakthrough Therapy Designation for
Shots: The BT Designation follows the P-II SPRINT trial assessing selumetinib as a monothx (PO) in paediatric patients, aged three years or older with inoperable NF1-related PN The ninth BT […]readmore
Regulatory
Novartis’s SEG101(crizanlizumab) Receives FDA’s Breakthrough Therapy(BT) Designation for Sickle Cell
Shots: The BTD is based on P-II SUSTAIN study results assessing crizanlizumab (5 mg/kg) vs PBO in patients with/without hydroxyurea therapy for preventing vaso-occlusive crises(VOCs) in SCD P-II SUSTAIN study […]readmore