Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 7

Results For "CHMP"

109 News Found

AstraZeneca’s Tezspire recommended for approval in the EU for chronic Rhinosinusitis with nasal polyps
News | September 23, 2025

AstraZeneca’s Tezspire recommended for approval in the EU for chronic Rhinosinusitis with nasal polyps

Tezspire nearly eliminated the need for surgery, reducing surgical intervention by 98 per cent


Novo Nordisk's oral semaglutide gets EU approval for heart related treatment of type 2 diabet
News | September 16, 2025

Novo Nordisk's oral semaglutide gets EU approval for heart related treatment of type 2 diabet

EU approval makes Novo Nordisk’s oral semaglutide the first and only oral GLP-1 RA to reduce cardiovascular death, heart attack and stroke


Gilead’s Yeytuo approved in EU for HIV prevention
Drug Approval | August 28, 2025

Gilead’s Yeytuo approved in EU for HIV prevention

This authorization follows FDA approval in June and WHO’s July recommendation adding twice-yearly lenacapavir as a PrEP option


Roche updates on Elevidys gene therapy for Duchenne muscular dystrophy in EU
News | July 31, 2025

Roche updates on Elevidys gene therapy for Duchenne muscular dystrophy in EU

Elevidys is currently the only approved gene therapy that targets the root cause of Duchenne


EMA starts review of sodium oxybate in alcohol dependence
Policy | June 28, 2025

EMA starts review of sodium oxybate in alcohol dependence

Review will evaluate effectiveness in treating alcohol withdrawal syndrome and supporting abstinence, as well as measures to mitigate risk of abuse


CuraTeQ Biologics receives positive opinion for biosimilar Dazublys from EMA
Drug Approval | April 28, 2025

CuraTeQ Biologics receives positive opinion for biosimilar Dazublys from EMA

Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein


CuraTeQ Biologics completes Phase 1 Pharmacokinetics study of biosimilar Denosumab
News | April 09, 2025

CuraTeQ Biologics completes Phase 1 Pharmacokinetics study of biosimilar Denosumab

This study enrolled a total of 204 healthy volunteers into three groups to compare BP16 with the reference products, Prolia, obtained from both the EU and US markets


European Commission approves Biocon Biologics' Ustekinumab Biosimilar
News | February 21, 2025

European Commission approves Biocon Biologics' Ustekinumab Biosimilar

YESINTEK, is intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn's disease


CuraTeQ Biologics receives positive opinion for biosimilar Dyrupeg from EMA
News | February 03, 2025

CuraTeQ Biologics receives positive opinion for biosimilar Dyrupeg from EMA

Dyrupeg will be available as 6 mg solution for injection in prefilled syringe and is intended for the reduction in the duration of neutropenia


Bayer’s pharma growth strategy progressing well as pipeline advances
News | January 15, 2025

Bayer’s pharma growth strategy progressing well as pipeline advances

Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid