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646 News Found

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


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


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


InnoCare announces priority review of Orelabrutinib for the treatment of R/R MZL by NMPA
News | September 06, 2022

InnoCare announces priority review of Orelabrutinib for the treatment of R/R MZL by NMPA

Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.


Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.1-adapted bivalent COVID-19 vaccine booster in EU
News | September 05, 2022

Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.1-adapted bivalent COVID-19 vaccine booster in EU

CHMP recommendation based on safety, tolerability, and immunogenicity data from a Phase 2/3 trial of the Omicron BA.1-adapted bivalent vaccine


USFDA approves first treatment option for generalized pustular psoriasis flares in adults
Drug Approval | September 03, 2022

USFDA approves first treatment option for generalized pustular psoriasis flares in adults

Spesolimab is a monoclonal antibody that inhibits interleukin-36 (IL-36) signaling and is the first treatment specifically approved for the treatment of generalized pustular psoriasis flares


Centre grants approval of three Bulk Drug Parks
Policy | September 02, 2022

Centre grants approval of three Bulk Drug Parks

The Bulk Drug Parks to be developed under the scheme will provide common infrastructure facilities at one place thereby creating a robust ecosystem for the bulk drug manufacturing in the country and also reducing manufacturing cost significantly


US FDA issues 17 observations for Biocon Biologics sites
News | September 01, 2022

US FDA issues 17 observations for Biocon Biologics sites

The observations primarily relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications & computerized tools


Stelis Biopharma’s flagship facility receives EIR from USFDA
Drug Approval | September 01, 2022

Stelis Biopharma’s flagship facility receives EIR from USFDA

The integrated capabilities at Unit 2 offer significant operational flexibility, greater efficiency, and varied scope within the same premise