Shots: OsteoBoost receives the US FDA’s BDD to reduce the risk of osteoporosis. It uses vibration technology that delivers mechanical stimulation to the hips & spine at a precise, individually […]readmore
Tags : Designation
Shots: This BT designation is based on P-IIb/III HPTN 083 study assessing cabotegravir (q8w) vs. FTC/TDF tablets (qd PO, 200/300 mg) in a study population of 4,566 for HIV prevention. […]readmore
Shots: The US FDA has granted ODD for branaplam in HD. In preclinical trials, branaplam demonstrated a reduction in levels of the mutant huntingtin protein. Additionally, the therapy showed a […]readmore
Shots: EMA’s COMP has granted a positive opinion for an ODD status to its PBP1510 for the treatment of pancreatic cancer. COMP’s positive will be sent to the EC which […]readmore
Shots: EMA has granted PRIME designation for iptacopan (LNP023) in C3 glomerulopathy (C3G). PRIME designation enhancing the development of medicine targeting unmet medical need. Results of P-II interim analysis for […]readmore
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
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
Shots: The Fast Track designation follows two P-III EMPEROR-Reduced & EMPEROR-Preserved studies assessing Empagliflozin (qd) vs PBO in 8,500+ patients with heart failure with reduced & preserved ejection fraction, both […]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