Medical Device | October 21, 2021
India approves LumiraDX’s Antigen test kit
The test combines sensitivity with speed and is designed to be used in health care settings to aid with rapid diagnosis of Covid-19
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
The revised deal involves a cash consideration only as against the earlier proposal of cash and equity
The company’s pharmaceutical API products Ibuprofen and fenofibrate got the go-ahead
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