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861 News Found

Aptar Digital Health and Healint collaborate for Central Nervous System
Digitisation | May 01, 2023

Aptar Digital Health and Healint collaborate for Central Nervous System

The partnership will capitalize on the combined capabilities of the two organizations


LyGenesis and Imagine Pharma to jointly develop cell therapies for Patients with Type 1 diabetes
News | April 12, 2023

LyGenesis and Imagine Pharma to jointly develop cell therapies for Patients with Type 1 diabetes

Collaboration will enable rapid advancement of a joint preclinical proof of concept program for type 1 diabetes


Lupin receives tentative approval from USFDA for Valbenazine capsules
Drug Approval | March 28, 2023

Lupin receives tentative approval from USFDA for Valbenazine capsules

Valbenazine Capsules (RLD Ingrezza) had estimated annual sales of USD 1,235 million in the U.S. (IQVIA MAT December 2022).


Lupin announces completion of pharmacovigilance inspection by USFDA
Drug Approval | March 27, 2023

Lupin announces completion of pharmacovigilance inspection by USFDA

The inspection included a comprehensive scrutiny of practices and procedures for reporting of adverse events of Lupin’s marketed products worldwide


Lupin receives tentative approval from USFDA for Obeticholic Acid Tablets
Drug Approval | March 24, 2023

Lupin receives tentative approval from USFDA for Obeticholic Acid Tablets

Obeticholic Acid Tablets (RLD Ocaliva) had estimated annual sales of US $255 million in the US (IQVIA MAT December 2022).


Lupin receives approval from USFDA for Brexpiprazole Tablets
Drug Approval | March 22, 2023

Lupin receives approval from USFDA for Brexpiprazole Tablets

Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, (RLD Rexulti) had estimated annual sales of US $1,575 million in the US (IQVIA MAT December 2022)


Caplin receives USFDA approval for Rocuronium Bromide Injection
Drug Approval | March 21, 2023

Caplin receives USFDA approval for Rocuronium Bromide Injection

Rocuronium Bromide Injection had an annual sale of approximately US $53 million in the US (IQVIA MAT December 2022)


USFDA completes inspection of Lupin’s Vizag facility
Drug Approval | March 11, 2023

USFDA completes inspection of Lupin’s Vizag facility

The inspection concluded with no observations