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

Results For "Center-for-Drug-Evaluation"

24 News Found

IOL Chemicals and Pharmaceuticals receives approval CDE of NMPA, China for Ibuprofen
Drug Approval | April 29, 2025

IOL Chemicals and Pharmaceuticals receives approval CDE of NMPA, China for Ibuprofen

This approval authorizes the company to export Ibuprofen to the Chinese markets


Morepen secures Loratadine approval for export to China
Drug Approval | April 01, 2025

Morepen secures Loratadine approval for export to China

This marks a significant milestone in Morepen’s strategic entry into one of the world’s largest pharmaceutical markets


Sanofi acquires rights to develop and commercialize Aficamten in Greater China
News | January 01, 2025

Sanofi acquires rights to develop and commercialize Aficamten in Greater China

In 2020, CORXEL acquired the rights to develop and commercialize aficamten in Greater China


Bayer starts Phase III trial in non-small cell lung cancer
Diagnostic Center | August 30, 2024

Bayer starts Phase III trial in non-small cell lung cancer

First patient enrolled in the Phase III SOHO-02 trial of investigational agent BAY 2927088 in treatment-naïve patients with advanced NSCLC with HER2-activating mutations


IOL Chemicals and Pharmaceuticals posts Q1 FY25 PAT at Rs. 29.7 Cr
News | August 10, 2024

IOL Chemicals and Pharmaceuticals posts Q1 FY25 PAT at Rs. 29.7 Cr

The company reported total income at Rs. 509.8 crore in Q1 FY25 as compared to Rs. 570.3 crore in Q1 FY24


NMPA accepts supplemental Biologics License Application for enfortumab vedotin with Keytruda for treatment of bladder cancer
Drug Approval | March 30, 2024

NMPA accepts supplemental Biologics License Application for enfortumab vedotin with Keytruda for treatment of bladder cancer

If approved, enfortumab vedotin with KEYTRUDA would be the first combination in China to offer an alternative to chemotherapy


Briefs: IOL Chemicals and Pharmaceuticals and Auro Peptides
News | February 20, 2024

Briefs: IOL Chemicals and Pharmaceuticals and Auro Peptides

IOL Chemicals and Pharmaceuticals’ product approved by CDE of NMPA, China


Innovent announces 2nd BTD by NMPA for Olverembatinib for treatment of patients with SDH-deficient GIST
Biotech | June 03, 2023

Innovent announces 2nd BTD by NMPA for Olverembatinib for treatment of patients with SDH-deficient GIST

Olverembatinib is the first and only third-generation BCR-ABL inhibitor approved in China for the treatment of adult patients with tyrosine kinase inhibitors


USFDA grants appeal for Ardelyx's XPHOZAH
Drug Approval | December 31, 2022

USFDA grants appeal for Ardelyx's XPHOZAH

Upon approval, XPHOZAH would be the first and only phosphate absorption inhibitor, offering patients a novel mechanism


BASF Pharma Solutions excipient accepted into FDA Pilot Program
Drug Approval | December 06, 2022

BASF Pharma Solutions excipient accepted into FDA Pilot Program

Soluplus branded excipient play a critical role in enabling the drug development process for poorly soluble active pharmaceutical ingredients