U.S. FDA expands approval of Dupixent to include children aged 6 to 11 years
Dupixent is the only biologic medicine to improve lung function in children aged 6 to 11 years in a randomized Phase 3 trial, supporting potential as a best-in-class option
Dupixent is the only biologic medicine to improve lung function in children aged 6 to 11 years in a randomized Phase 3 trial, supporting potential as a best-in-class option
It has exercised intellectual property options from IP Group regarding research results generated by the UK Cystic Fibrosis Gene Therapy Consortium, and from Oxford Biomedica regarding their lentiviral vector technology
The test combines sensitivity with speed and is designed to be used in health care settings to aid with rapid diagnosis of Covid-19
Following the pre-NDA meeting with the U.S. FDA, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD
The company proposes to invest up to US $ 50 million, over a period of five years, starting from FY22, to support capability development of talent and technology
Second interchangeable biosimilar product approved by agency
The company is eligible for 180 days of generic drug exclusivity for Lenalidomide capsules, 2.5 mg and 20 mg
The first patient dosed with VX-880 demonstrated restoration of insulin production and achieved C-peptide of 560 pmol/L in response to Mixed Meal Tolerance Test (MMTT) at Day 90 visit
Tecentriq is the first and only cancer immunotherapy approved for NSCLC in the adjuvant setting
The capsules are indicated for the maintenance of normal sinus rhythm in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm
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