Shots: NICE has issued a positive Final Appraisal Document which recommends Sunosi (75/150mg, qd) as an option treatment for adults with EDS caused by narcolepsy with/out cataplexy. The therapy will […]readmore
Tags : Recommendation
Shots: The NICE has recommended Novartis’ Adakveo (crizanlizumab) as a new treatment option to prevent recurrent sickle cell crises in patients aged ≥16 Additionally, patients will now have access to […]readmore
Shots: The US FDA’s CRDAC voted 12 to 1 supporting the use of Entresto (sacubitril/valsartan) in the treatment of patients with HFpEF The decision was based on efficacy & safety […]readmore
Shots: The NICE has issued FAD which is based on the P-III ICARIA-MM trial assessing isatuximab + pom-dex vs pom-dex in patients prior treated with 3L treatment and at least […]readmore
Shots: The US FDA’s ODAC has voted 12-0 in favor of the demonstrated benefit of belantamab mafodotin monothx. outweighing the risks for patients with r/r MM prior treated with at […]readmore
Pharma
Regulatory
Novartis’ Enerzair Breezhaler (QVM149, IND/GLY/MF) Receives CHMP’s Recommendation for Approval
Shots: The CHMP’s recommendation is based on P-III IRIDIUM study assessing IND/GLY/MF (150/50/160 μg & 150/50/80 μg) vs IND/MF doses (150/320 μg & 150/160 μg) in 3,092 patients in a […]readmore
Shots: The CHMP’s positive recommendation is based on the clinical development program that comprises P-I PK/PD study that evaluates product’s similarity in exposure and activity1 and P-III Gemelli 12 study […]readmore
Shots: The EMA’s CHMP has adopted a positive opinion on a dosing and administration label update for AstraZeneca’s Lokelma to include patients with hyperkalemia on stable hemodialysis The recommendation is […]readmore
Shots: The US FDA’s ODAC voted 7 to 5 in favor of recommending Lynparza as 1L maintenance monotherapy for patients with gBRCAm metastatic adenocarcinoma of the pancreas that has not […]readmore
Shots: The US FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted 9-4 in favor of recommending Keytruda for bacillus Calmette-Guérin-unresponsive, high risk NMIBC with carcinoma in-situ with/ out papillary tumors […]readmore