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3556 News Found

Hutchmed completes rolling submission of NDA to USFDA for fruquintinib
Drug Approval | April 03, 2023

Hutchmed completes rolling submission of NDA to USFDA for fruquintinib

NDA supported by data from global Phase III FRESCO-2 study in the U.S., Europe, Japan and Australia along with data from Phase III FRESCO study conducted in China


Evonik starts construction of US$220 million lipid innovation center in Lafayette
News | March 31, 2023

Evonik starts construction of US$220 million lipid innovation center in Lafayette

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


Alembic receives USFDA final approval for Brimonidine Tartrate Ophthalmic Solution
Drug Approval | March 31, 2023

Alembic receives USFDA final approval for Brimonidine Tartrate Ophthalmic Solution

Brimonidine Tartrate Ophthalmic Solution is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure


Granules India receives ANDA approval for Gabapentin Tablets
Drug Approval | March 30, 2023

Granules India receives ANDA approval for Gabapentin Tablets

Gabapentin Tablets are indicated for management of postherpetic neuralgia in adults


MPP signs sublicences with Aurobindo, Cipla and Viatris to produce generic versions of HIV prevention medicine
News | March 30, 2023

MPP signs sublicences with Aurobindo, Cipla and Viatris to produce generic versions of HIV prevention medicine

Licences should enable potentially millions of people living in areas most impacted by HIV to access this innovative prevention medicine through low-cost generic manufacturers


Agilent presents 2023 Darlene Solomon Award to Kathryn Wolhuter
People | March 28, 2023

Agilent presents 2023 Darlene Solomon Award to Kathryn Wolhuter

The award recognizes and supports promising female scientists working in mass spectrometry


Thermo Fisher Scientific opens cell therapy facility at University of California
News | March 28, 2023

Thermo Fisher Scientific opens cell therapy facility at University of California

The San Francisco facility is part of Thermo Fisher’s global pharma services network of more than 15 locations supporting cell and gene therapies.


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