Shots: The US FDA has approved Semglee (insulin glargine-yfgn injection) as the first interchangeable biosimilar product under the 351(k) regulatory pathways to treat diabetes Semglee will allow pharmacy level substitution […]readmore
Tags : approval
Shots: The approval is based on two P-III studies that evaluate Twyneo vs vehicle in adults & pediatric patients aged ≥9yrs. with acne vulgaris which demonstrated an efficacy & a […]readmore
Shots: The approval is based on studies evaluating the safety & efficacy of Shingrix in adults aged ≥18yrs. who had undergone auHSCT and those undergoing treatment for hematological malignancies (post-hoc […]readmore
Regulatory
Alexion’s Ultomiris (ravulizumab) Receives CHMP’s Positive Opinion Recommending its Approval
Shots: The CHMP’s positive opinion is based on a P-III study assessing Ultomiris and showed effectiveness in completing C5 complement inhibition @26wks. for children & adolescents aged ≤18yrs. with PNH […]readmore
In an interview with PharmaShots, Dave Marek. CEO of Myovant shares insights on the US FDA’s approval of Myfembree (relugolix 40mg, estradiol 1mg, and norethindrone acetate 0.5mg) in Uterine Fibroids. […]readmore
Shots: The approval is based on safety & efficacy data from the P-III LIBERTY program that consists of 2 studies i.e LIBERTY 1 & 2 evaluating Ryeqo in adult women […]readmore
Shots: The approval is based on KD025-213 study evaluating Rezurock (200 mg, qd) aged >12 yrs. in 65 patients with cGVHD who had received 2 to 5 prior lines of […]readmore
Regulatory
Regeneron’s Ronapreve Antibody Cocktail (casirivimab and imdevimab) Receives MHLW’s Approval
Shots: The approval is based on the results from a P-III trial evaluating Ronapreve (casirivimab and imdevimab) in high-risk non-hospitalized patients with COVID-19 The results showed a reduction in the […]readmore
Biotech
Regulatory
Merck’s Vaxneuvance (pneumococcal 15-valent conjugate vaccine) Receives the US FDA’s
Shots: The approval is based on seven P-II & III clinical studies involves assessing the safety, tolerability & immunogenicity of Vaxneuvance vs PCV13 in 7,438 adults aged >18yrs. with IPD […]readmore
Regulatory
Janssen’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) + Pomalidomide and Dexamethasone
Shots: The approval is based on P-III APOLLO study evaluating Darzalex Faspro (SC) + pomalidomide & dexamethasone (Pd) vs Pd alone in 304 patients with RRMM who have received at […]readmore