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3349 News Found

NMDP focuses on smooth transition to licensing of Class-A and B medical devices
News | September 15, 2022

NMDP focuses on smooth transition to licensing of Class-A and B medical devices

The Department of Health and Family Welfare updated the preparedness for transition to licensing of Class-A and Class-B medical devices with effect from 1st October, 2022 under Medical Devices Rules 2017


Zydus receives final approval from USFDA for Cariprazine Capsules
Drug Approval | September 15, 2022

Zydus receives final approval from USFDA for Cariprazine Capsules

Cariprazine is an atypical antipsychotic indicated for the treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar I disorder


Lupin receives Health Canada approval for Rymti
Drug Approval | September 14, 2022

Lupin receives Health Canada approval for Rymti

Rymti is indicated in the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis, and paediatric plaque psoriasis


Takara Bio partners with BioeXsen for the distribution of CE-IVD solutions
Supply Chain | September 14, 2022

Takara Bio partners with BioeXsen for the distribution of CE-IVD solutions

The reliability of their products, evidenced by their inclusion in the WHO emergency use list, has further improved with the addition of Takara Bio's enzymes.


Merck and Eisai present results from Phase 3 LEAP-002 Trial evaluating KEYTRUDA
Clinical Trials | September 12, 2022

Merck and Eisai present results from Phase 3 LEAP-002 Trial evaluating KEYTRUDA

Findings to be featured in a late-breaking proffered paper session at European Society for Medical Oncology (ESMO) Congress 2022


Panacea Biotec received US FDA communication for Baddi facility
Drug Approval | September 09, 2022

Panacea Biotec received US FDA communication for Baddi facility

The OAI classification implies that the USFDA expects further corrective actions and may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved


Cipla receives US FDA approval for Revlimid (Lenalidomide) capsules
Drug Approval | September 08, 2022

Cipla receives US FDA approval for Revlimid (Lenalidomide) capsules

Depending on the type of cancer, it can be used as monotherapy or combination as a part of first line regimen, maintenance regimen or relapsed settings


World’s first intra nasal vaccine iNCOVACC from Bharat Biotech receives approval
Drug Approval | September 07, 2022

World’s first intra nasal vaccine iNCOVACC from Bharat Biotech receives approval

iNCOVACC was developed in partnership with Washington University St. Louis, which had designed and developed the recombinant adenoviral vectored constructs and evaluated them in preclinical studies for efficacy


Balaxi Pharma to issue Rs. 49.61 crore Equity Shares/Warrants
News | September 06, 2022

Balaxi Pharma to issue Rs. 49.61 crore Equity Shares/Warrants

Proceeds from the proposed issue will be utilized to part finance Balaxi’s planned EU GMP-compliant manufacturing facility for Oral Solid Dosages and Liquid Injectables at TSIIC Pharma Formulations SEZ


Boehringer Ingelheim InPedILD Phase III trial showed encouraging results for both primary endpoints
Clinical Trials | September 06, 2022

Boehringer Ingelheim InPedILD Phase III trial showed encouraging results for both primary endpoints

New data from Boehringer Ingelheim support the potential use of nintedanib in children and adolescents with fibrosing interstitial lung disease