Shots: The P-III study involves assessing Xywav vs PBO in patients aged ≥ 7yrs. with cataplexy or EDS with narcolepsy Results: study met its 1EPs & 2EPs i.e. differences in […]readmore
Tags : Oral
Shots: The NDA submission is based on FIREFISH study assessing Risdiplam in infants with symptomatic SMA Type 1 & SUNFISH study in children and young adults with SMA Type 2 […]readmore
Shots: Dogma to receive upfront along with global regulatory and commercial milestones. AstraZeneca to get the rights to an orally active drug inhibiting PCSK9, offering a patient-friendly alternative to current […]readmore
Shots: Athena Biosciences announced that the US FDA has approved Qdolo (tramadol hydrochloride) oral solution 5mg/1mL C-IV The most common AE’s (≥15.0%) observed in patients were dizziness/vertigo, nausea, constipation, headache, […]readmore
Shots: The approval follows P-III ELARIS UF-I and ELARIS UF-II studies assessing Oriahnn (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) vs PBO for the management of heavy menstrual bleeding […]readmore
Shots: Protagonist to receive $25M upfront, $1.0B as development, regulatory & commercial milestones & royalties on product sales with rights to co-detail both products. Janssen to get exclusive WW rights […]readmore