News | June 23, 2022
Glenmark Pharmaceuticals to address USFDA’s observation
U.S. FDA has issued Form 483 with six observations after an inspection of the company’s formulation manufacturing facility based out of Baddi
U.S. FDA has issued Form 483 with six observations after an inspection of the company’s formulation manufacturing facility based out of Baddi
Intended for potential treatment of ER+/HER2- advanced or metastatic breast cancer patients
With this designation, LG Chem will receive benefits such as exclusive sales rights in the US market for seven years, subsidies and tax cuts for clinical testing costs in the US, and preliminary consulting support related to development
Alopecia areata usually presents as a few small bald patches in the head
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.
Dupixent is the first and only biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy to adulthood
he approved product has an estimated market size of US$ 83 million for the twelve months ending April 2022, according to IQVIA.
Ivacaftor Tablets had estimated annual sales of USD 109 million in the US.
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