Drug Approval | June 14, 2022
FDA accepts application for Merck’s Keytruda as adjuvant therapy for Stage IB-IIIA lung cancer
Acceptance based on results from the phase 3 KEYNOTE-091 trial
Acceptance based on results from the phase 3 KEYNOTE-091 trial
Marinus has broadened inclusion criteria in the RAISE trial to allow for enrollment of patients previously treated with IV anesthesia.
Dupixent is the first and only biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy to adulthood
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.
TLANDO was approved by the U.S. Food and Drug Administration (FDA) on March 28, 2022.
If approved, Tafinlar + Mekinist may offer a potential new standard-of-care for pediatric patients with this brain cancer
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
Dr. Bernstein will tap into her decades of leadership and strategy experience as she transitions into this new role at APhA
Radicava ORS was approved by the U.S. Food and Drug Administration (FDA) on May 12, 2022
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