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Zydus announces update on a randomised trial of Saroglitazar Mg in NASH
Biotech | October 22, 2021

Zydus announces update on a randomised trial of Saroglitazar Mg in NASH

Incidences of Non-alcoholic Fatty Liver Disease (NAFLD) have been rising exponentially worldwide and are associated with co-morbidities including obesity, diabetes, hypertension and metabolic disorders


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


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


U.S. FDA gives green light to Moderna and J&J booster doses
Drug Approval | October 21, 2021

U.S. FDA gives green light to Moderna and J&J booster doses

The authority also allowed mix and match of booster doses once the primary vaccine has been administered.


Biocon Biologics’ interchangeable biosimilar insulin Glargine preferred on Express Scripts
News | October 21, 2021

Biocon Biologics’ interchangeable biosimilar insulin Glargine preferred on Express Scripts

Express Scripts, a leading pharmacy benefit management organization, will list Viatris labelled biosimilar insulin Glargine as a preferred insulin brand on its National Preferred Formulary (NPF)


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


U.S. FDA authorises new saliva sample collection for Covid-19
Medical Device | October 19, 2021

U.S. FDA authorises new saliva sample collection for Covid-19

The Amplitude Solution gives laboratories the ability to scale Covid-19 PCR testing and process up to 8,000 samples a day


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


Luke Coutinho launches e-commerce venture YouCareLifestyle
Healthcare | October 19, 2021

Luke Coutinho launches e-commerce venture YouCareLifestyle

The platform will be a curated marketplace for sustainable-driven products by small-medium entrepreneurs and will encourage an autonomous marketplace


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