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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


Evonik starts construction of new U.S. facility for pharmaceutical lipids
News | April 29, 2023

Evonik starts construction of new U.S. facility for pharmaceutical lipids

Cooperative agreement with U.S. Government to advance U.S. biopharma industry and ensure pandemic preparedness


Ipca Laboratories gets 3 observations for Piparia, Silvassa unit
Drug Approval | April 27, 2023

Ipca Laboratories gets 3 observations for Piparia, Silvassa unit

The company will submit its comprehensive response on these observations to the US FDA within the stipulated time


Xyall and Indica Labs forge collaboration to transform precision oncology workflows
News | April 25, 2023

Xyall and Indica Labs forge collaboration to transform precision oncology workflows

Bridging the gap between histopathology and molecular pathology


Zydus receives final approval from the USFDA for Metronidazole Topical Cream
Drug Approval | April 25, 2023

Zydus receives final approval from the USFDA for Metronidazole Topical Cream

Metronidazole is an antibiotic used on the skin to treat a certain skin disorder known as rosacea


Zydus receives final approval from the USFDA for Icosapent Ethyl Capsules
Drug Approval | April 24, 2023

Zydus receives final approval from the USFDA for Icosapent Ethyl Capsules

Icosapent Ethyl Capsules are indicated as an adjunct to diet to reduce triglyceride levels


USFDA suggests corrective measures to Sun Pharmaceutical’s Mohali facility
Drug Approval | April 24, 2023

USFDA suggests corrective measures to Sun Pharmaceutical’s Mohali facility

The USFDA had classified the inspection as "Official Action Indicated" (OAI).


USFDA lifts clinical hold on Phase 3 investigational new drug application for MaaT013
Drug Approval | April 24, 2023

USFDA lifts clinical hold on Phase 3 investigational new drug application for MaaT013

This is the first time the Agency has authorized the Phase 3 clinical evaluation in the U.S of a microbiota-based live biotherapeutic based on a pooling technology


LTS acquires Sorrel wearable injection device business
News | April 22, 2023

LTS acquires Sorrel wearable injection device business

The acquisition is a crucial step in LTS' strategy to broaden its portfolio of drug delivery platforms.