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
Dasatinib Tablet is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive
Strides was granted a Competitive Generic Therapy (CGT) designation for its ANDA.
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.
States have an important role in ensuring food safety and healthy food practices.
If approved, Tafinlar + Mekinist may offer a potential new standard-of-care for pediatric patients with this brain cancer
he approved product has an estimated market size of US$ 83 million for the twelve months ending April 2022, according to IQVIA.
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