Mallinckrodt launches Lisdexamfetamine Dimesylate Capsules for ADHD after FDA approval
The FDA has approved the firm’s ANDA for Lisdexamfetamine Dimesylate Capsules 10mg, 20mg, 30mg, 40mg, 50mg, 60mg, and…
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01 Sep 23
The FDA has approved the firm’s ANDA for Lisdexamfetamine Dimesylate Capsules 10mg, 20mg, 30mg, 40mg, 50mg, 60mg, and…
29 Aug 23
The sNDA filing was based on the data from Cohort 1 of the late-stage THOR trial in which…
25 Aug 23
Japan’s MHLW expands Soliris’ indication to include children who are anti-acetylcholine receptor (AChR) antibody-positive, for whom high-dose intravenous…
25 Aug 23
The marketing authorisation was based on the findings of the MATISSE and RENOIR clinical trials and follows a…
24 Aug 23
FDA accepted Pfizer and Astellas’ supplemental New Drug Application (sNDA) for Xtandi, expanding its indication to include patients…
22 Aug 23
Abrysvo, a bivalent RSV prefusion F (RSVpreF) vaccine that contains two preF proteins to optimise the protection against…
21 Aug 23
Eylea is a vascular endothelial growth factor (VEGF) inhibitor that blocks the growth of new blood vessels in…
21 Aug 23
The sNDA is supported by the full data set from the Phase 3 randomised, double-blind, multicenter NefIgArd clinical…
18 Aug 23
Aquipta is a once-daily oral calcitonin gene-related peptide (CGRP) receptor antagonist approved for the prophylaxis of migraine in…
17 Aug 23
Sohonos is particularly selective for the gamma subtype of retinoic-acid receptors and mediates the interactions between the receptors,…