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3136 News Found

Alembic announces USFDA tentative approval for Selexipag for Injection, 1,800 mcg/vial
Drug Approval | July 14, 2024

Alembic announces USFDA tentative approval for Selexipag for Injection, 1,800 mcg/vial

Selexipag is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension


7th India-Japan medical product regulatory symposium held at New Delhi
Policy | July 14, 2024

7th India-Japan medical product regulatory symposium held at New Delhi

Enhanced collaboration under the Memorandum of Cooperation (MoC) between India and Japan in medical product regulations


Lupin receives EIR from USFDA for its Dabhasa  facility
Drug Approval | July 13, 2024

Lupin receives EIR from USFDA for its Dabhasa facility

The facility is a part of Lupin Manufacturing Solutions


Alembic Pharmaceuticals announces USFDA Final Approval for Bromfenac Ophthalmic Solution, 0.07%
Drug Approval | July 10, 2024

Alembic Pharmaceuticals announces USFDA Final Approval for Bromfenac Ophthalmic Solution, 0.07%

The approved ANDA is therapeutically equivalent to the reference listed drug product


Zydus receives final approval from USFDA for Sacubitril and Valsartan Tablets
Drug Approval | July 10, 2024

Zydus receives final approval from USFDA for Sacubitril and Valsartan Tablets

Sacubitril and Valsartan combination is used to treat chronic heart failure in adults


Zydus receives tentative approval from USFDA for Diroximel Fumarate DR Capsules
Drug Approval | July 10, 2024

Zydus receives tentative approval from USFDA for Diroximel Fumarate DR Capsules

Diroximel Fumarate Delayed-Release Capsules is indicated for the treatment of relapsing forms of multiple sclerosis


Lupin receives tentative approval from USFDA for Empagliflozin, Linagliptin and Metformin Hydrochloride ER tablets
Drug Approval | July 10, 2024

Lupin receives tentative approval from USFDA for Empagliflozin, Linagliptin and Metformin Hydrochloride ER tablets

This product will be manufactured at Lupin’s Pithampur facility in India


AbbVie appoints Roopal Thakkar as EVP, Research & Development and Chief Scientific Officer
People | July 10, 2024

AbbVie appoints Roopal Thakkar as EVP, Research & Development and Chief Scientific Officer

Dr. Roopal Thakkar joined Abbott/AbbVie in 2003 as part of the Physician Development Program


Olverembatinib approved for commercialization in Macau China
Drug Approval | July 09, 2024

Olverembatinib approved for commercialization in Macau China

Olverembatinib, a novel drug developed by Ascentage Pharma with support from the National Major New Drug Development program


Ligand to acquire Apeiron Biologics for US$100 million
News | July 09, 2024

Ligand to acquire Apeiron Biologics for US$100 million

Acquisition provides Ligand with the royalty rights to QARZIBA, a highly differentiated, commercial oncology drug marketed in 35 countries by global pharmaceutical company Recordati S.p.A.