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646 News Found

US FDA accepts new drug application filed by Avillion for AstraZeneca's PT027
Drug Approval | June 01, 2022

US FDA accepts new drug application filed by Avillion for AstraZeneca's PT027

Avillion announces expansion of partnership with AstraZeneca on PT027 and will fund and execute a new Phase 3b study


Alembic Pharmaceuticals receives USFDA final approval for Pirfenidone tablets
Drug Approval | May 24, 2022

Alembic Pharmaceuticals receives USFDA final approval for Pirfenidone tablets

The tablets have an estimated market size of US $ 548 million for twelve months ending December 2021 according to IQVIA


AbbVie showcases its leadership in Rheumatology research with new data across multiple inflammatory joint diseases
Biotech | May 24, 2022

AbbVie showcases its leadership in Rheumatology research with new data across multiple inflammatory joint diseases

The hybrid congress will take place from 1-4 June in Copenhagen, as well as virtually


Dapagliflozin met primary endpoint in DELIVER Phase III trial
Biotech | May 23, 2022

Dapagliflozin met primary endpoint in DELIVER Phase III trial

Results from the DELIVER and DAPA-HF Phase III trials demonstrate Dapagliflozin’ efficacy in heart failure regardless of ejection fraction


Novavax files for expanded conditional marketing authorisation for Nuvaxovid as a booster in Europe
News | May 21, 2022

Novavax files for expanded conditional marketing authorisation for Nuvaxovid as a booster in Europe

The European Commission granted CMA in December 2021 for use of Nuvaxovid in individuals aged 18 and over, and Novavax filed for expanded CMA for use in adolescents aged 12 through 17 in March 2022


USFDA approves Dupixent as first treatment for 12 and older with eosinophilic esophagitis
Drug Approval | May 21, 2022

USFDA approves Dupixent as first treatment for 12 and older with eosinophilic esophagitis

Dupixent is the first and only medicine indicated to treat eosinophilic esophagitis in the United States; approval granted more than two months ahead of USFDA’s Priority Review action date


Pfizer and BioNTech granted U.S. EUA for booster dose for kids 5-11 years
Drug Approval | May 18, 2022

Pfizer and BioNTech granted U.S. EUA for booster dose for kids 5-11 years

Children 5 through 11 years of age are now authorized to receive a booster dose at least five months after the second dose of the two-dose primary series


Moderna announces advancements in mRNA platform science for application across multiple diseases
Biotech | May 17, 2022

Moderna announces advancements in mRNA platform science for application across multiple diseases

Moderna continues to expand its mRNA platform for a range of additional clinical applications and routes of administration including a modality for lung delivery


Akston Biosciences doses first participants in Phase II clinical trial for Covid-19 booster
Biotech | May 13, 2022

Akston Biosciences doses first participants in Phase II clinical trial for Covid-19 booster

AKS-452 is currently undergoing Phase II/III clinical testing in India as a primary vaccine; submission for Emergency Use Authorization (EUA) expected by Q3 2022


Neurocrine Biosciences receives Orphan Drug Designation for Valbenazine
Biotech | May 13, 2022

Neurocrine Biosciences receives Orphan Drug Designation for Valbenazine

The treatment of chorea associated with HD is within the scope of this Orphan Drug Designation