It is one of the first companies to launch a bioequivalent version of the dry powder inhaler and it's part of the company’s strategic exclusive in-licensing arrangement to market Tiotropium DPI in Western Europe and the UK
The rolling submission to the U.S. FDA will begin in the fourth quarter of this year
The company has already received the emergency use authorization (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D to be administered in three doses on August 20
The CAC solution cleared by the U.S. FDA analyses already existing non-gated CT scans and quantifies the coronary artery calcium in order to identify, stratify, and facilitate treatment pathways for patients with cardiovascular disease
The company is the Clinical Research Organisation of Caplin Point Laboratories
Emergency Use Authorisation (EUA) is granted for individuals 65 years of age and older, and individuals ages 18 through 64 within certain high-risk groups
In participants 5 to 11 years of age, the vaccine was safe, well-tolerated and showed robust neutralising antibody responses. Results in children under 5 years of age are expected as soon as later this year
With the MONALEESA-2 final analysis, only Kisqali has reported statistically significant overall survival (OS) benefit with an aromatase inhibitor for postmenopausal women with HR+/HER2- advanced breast cancer in the first-line (1L) setting
The recommendation is based on positive results from the pivotal Phase 3 CheckMate -649 trial in which Opdivo plus chemotherapy demonstrated superior overall survival versus chemotherapy
It tests for the presence or absence of ribonucleic acid (RNA) of Dengue (Type 1, 2 4) in serum or plasma from patients suspected of dengue viral infection.
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