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Results For "ANDA"

2098 News Found

Zion Pharma inks agreement with Roche to develop and commercialize brain-penetrable compounds
News | May 10, 2023

Zion Pharma inks agreement with Roche to develop and commercialize brain-penetrable compounds

ZN-A-1041 was designed to be blood-brain-barrier-penetrant, and has the potential to treat or prevent the onset of brain metastases in patients with HER2-positive metastatic breast cancer


Dr Bharati Pravin Pawar launches Phase-III of Thalassemia Bal Sewa Yojana
Policy | May 09, 2023

Dr Bharati Pravin Pawar launches Phase-III of Thalassemia Bal Sewa Yojana

Launches Thalassemia Bal Sewa Yojana portal and releases standard treatment guidelines for sickle cell anemia disease


Baxter  to sell its BioPharma Solutions Business to Advent International and Warburg Pincus for US $4.25billion
News | May 09, 2023

Baxter to sell its BioPharma Solutions Business to Advent International and Warburg Pincus for US $4.25billion

Proposed divestiture of BioPharma Solutions (BPS) further streamlines Baxter’s strategic focus and represents an important milestone in its ongoing business transformation


Galmed Pharmaceuticals forms partnership with OnKai
News | May 08, 2023

Galmed Pharmaceuticals forms partnership with OnKai

Both the companies intend to facilitate faster clinical trial enrollment and provide patients with access to novel medications


Hyderabad startup’s Physiotherapy monitoring device ‘Pheezee’ receives USFDA
Medical Device | May 05, 2023

Hyderabad startup’s Physiotherapy monitoring device ‘Pheezee’ receives USFDA

Pheezee is designed to assess musculoskeletal and neuromuscular health.


Indoco receives EIR for its Plant I manufacturing facility in Goa
Drug Approval | May 04, 2023

Indoco receives EIR for its Plant I manufacturing facility in Goa

Indoco expects this change in compliance status to pave the way for approvals of ANDAs submitted from this site.


AstraZeneca Pharma India receives permission for sale and distribution of Trastuzumab deruxtecan
News | May 04, 2023

AstraZeneca Pharma India receives permission for sale and distribution of Trastuzumab deruxtecan

The receipt of this permission paves way for the launch of Trastuzumab deruxtecan (Enhertu) solution of 100mg/5mL in India


CHMP recommends EU approval of Roche’s fixed-duration Columvi for large B-cell lymphoma
Drug Approval | May 02, 2023

CHMP recommends EU approval of Roche’s fixed-duration Columvi for large B-cell lymphoma

Once approved, Columvi will be the first CD20xCD3 T-cell-engaging bispecific antibody available to treat people in Europe with this aggressive lymphoma


Biocon Biologics' new mAbs facility receives EU GMP Certification for bBevacizumab
News | April 29, 2023

Biocon Biologics' new mAbs facility receives EU GMP Certification for bBevacizumab

This approval reflects Biocon Biologics' compliance with the highest international regulatory standards