Drug Approval | June 12, 2022
Strides receives USFDA approval for Ibuprofen OTC oral suspension
Strides was granted a Competitive Generic Therapy (CGT) designation for its ANDA.
Strides was granted a Competitive Generic Therapy (CGT) designation for its ANDA.
Bayer now present in four of the largest biotechnology hubs in the United States
TP-3654 is currently being evaluated in a Phase 1/2, multicenter, dose-escalation, open-label trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with intermediate or high-risk primary or secondary myelofibrosis.
Efgartigimod is approved in the United States as VYVGART for the treatment of adults with generalized myasthenia gravis
Based on a post hoc analysis, fewer required respiratory interventions
Ivacaftor Tablets had estimated annual sales of USD 109 million in the US.
The drug will be manufactured at the group’s topical facility at Ahmedabad
82.5% of patients treated at 10mg dose of obicetrapib achieved LDL-c target of <70 mg/dL, compared to 20% of patients treated with placebo
Immune-mediated events and infusion reactions were higher with KEYTRUDA (38% vs 9%, respectively).
Construction will begin in early 2023, and the plant is scheduled to go onstream in 2025
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