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Results For "AP"

8937 News Found

U.S. FDA expands approval of Dupixent to include children aged 6 to 11 years
Drug Approval | October 22, 2021

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


Boehringer Ingelheim and partners to develop gene therapy for patients with cystic fibrosis
Biotech | October 21, 2021

Boehringer Ingelheim and partners to develop gene therapy for patients with cystic fibrosis

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


India approves LumiraDX’s Antigen test kit
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


Sage Therapeutics and Biogen plan to submit a New Drug Application (NDA) for zuranolone
Biotech | October 21, 2021

Sage Therapeutics and Biogen plan to submit a New Drug Application (NDA) for zuranolone

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


Medtronic announces launch of Open Innovation Platform for APAC
Digitisation | October 20, 2021

Medtronic announces launch of Open Innovation Platform for APAC

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


FDA approves Cyltezo, the first interchangeable biosimilar to Humira
Drug Approval | October 20, 2021

FDA approves Cyltezo, the first interchangeable biosimilar to Humira

Second interchangeable biosimilar product approved by agency


Dr Reddy’s Labs announces U.S. FDA approval for Lenalidomide capsules
Drug Approval | October 19, 2021

Dr Reddy’s Labs announces U.S. FDA approval for Lenalidomide capsules

The company is eligible for 180 days of generic drug exclusivity for Lenalidomide capsules, 2.5 mg and 20 mg


Vertex’s stem cell therapy for Type 1 diabetes reduced daily insulin requirement by 91 %
Biotech | October 19, 2021

Vertex’s stem cell therapy for Type 1 diabetes reduced daily insulin requirement by 91 %

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


U.S. FDA approves Roche’s Tecentriq as adjuvant treatment for small cell lung cancer
Drug Approval | October 18, 2021

U.S. FDA approves Roche’s Tecentriq as adjuvant treatment for small cell lung cancer

Tecentriq is the first and only cancer immunotherapy approved for NSCLC in the adjuvant setting


Granules gets ANDA approval for Dofetilide capsules
Drug Approval | October 18, 2021

Granules gets ANDA approval for Dofetilide capsules

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