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Results For "phase-3"

732 News Found

Biohaven and Pfizer announce positive topline results of rimegepant to treat migrane
Biotech | February 14, 2022

Biohaven and Pfizer announce positive topline results of rimegepant to treat migrane

Rimegepant is the first oral calcitonin gene-related peptide receptor antagonist to demonstrate positive results in a pivotal trial in the Asia Pacific


Novavax Covid-19 vaccine well tolerated in paediatric population
Biotech | February 11, 2022

Novavax Covid-19 vaccine well tolerated in paediatric population

Immune responses were about two-to-three-fold higher in adolescents than in adults against all variants studied. Vaccine was well-tolerated with no safety signals identified


USFDA awards QIDP designation for prevention of chlamydia to Evofem Biosciences
Drug Approval | February 10, 2022

USFDA awards QIDP designation for prevention of chlamydia to Evofem Biosciences

Adds five years of market exclusivity on approval


Gamida Cell initiates rolling submission of Biologics License Application for Omidubicel
Biotech | February 10, 2022

Gamida Cell initiates rolling submission of Biologics License Application for Omidubicel

On track to complete the BLA submission in the first half of 2022


Glenmark launches nasal spray to treat Covid-19
News | February 09, 2022

Glenmark launches nasal spray to treat Covid-19

Glenmark received manufacturing and marketing approval from DCGI for Nitric Oxide Nasal Spray (NONS) as part of accelerated approval process


Moderna’s Covid-19 `Spikevax’ vaccine gets full USFDA approval
Biotech | February 01, 2022

Moderna’s Covid-19 `Spikevax’ vaccine gets full USFDA approval

Spikevax has received approval by regulators in more than 70 countries, including Canada, Japan, the European Union, the UK, Israel


European Commission approves Merck’s KEYTRUDA as adjuvant therapy for RCC
Drug Approval | January 28, 2022

European Commission approves Merck’s KEYTRUDA as adjuvant therapy for RCC

KEYTRUDA is now approved as monotherapy for adults with Renal Cell Carcinoma (RCC)


Pfizer and BioNTech evaluate Omicron specific Covid-19 vaccine
News | January 25, 2022

Pfizer and BioNTech evaluate Omicron specific Covid-19 vaccine

First participants enrolled in clinical trial received Omicron-based vaccine candidate as a two-dose primary series and as a booster dose


US FDA approves Idorsia’s insomnia drug
Drug Approval | January 21, 2022

US FDA approves Idorsia’s insomnia drug

Quviviq is a dual orexin receptor antagonist, which blocks the binding of the wake-promoting neuropeptides orexins and is thought to turn down overactive wakefulness, as opposed to treatments that generally sedate the brain


Novo Nordisk India launches world’s first and only GLP-1 RA, oral semaglutide
Drug Approval | January 20, 2022

Novo Nordisk India launches world’s first and only GLP-1 RA, oral semaglutide

Oral semaglutide is a co-formulation of GLP-1RA semaglutide with an absorption enhancer SNAC which protects semaglutide from undergoing degradation in the stomach