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389 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


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


USDA approves Merck Animal Health’s NOBIVAC NXT canine flu H3N2
Drug Approval | June 26, 2024

USDA approves Merck Animal Health’s NOBIVAC NXT canine flu H3N2

Innovative technology represents a breakthrough scientific achievement for highly contagious respiratory disease


Bristol Myers Squibb receives USFDA accelerated approval of Krazati in combination with Cetuximab for CRC
Drug Approval | June 22, 2024

Bristol Myers Squibb receives USFDA accelerated approval of Krazati in combination with Cetuximab for CRC

Second FDA approval for KRAZATI - reinforcing its potential across tumor types


Alembic Pharmaceuticals gets USFDA final approval for Dabigatran Etexilate capsules
Drug Approval | June 19, 2024

Alembic Pharmaceuticals gets USFDA final approval for Dabigatran Etexilate capsules

Dabigatran Etexilate Capsules are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients


USFDA completes audit of contract manufacturing facility of Jubilant Pharmova Montreal unit
Drug Approval | June 19, 2024

USFDA completes audit of contract manufacturing facility of Jubilant Pharmova Montreal unit

The USFDA has issued 15 observations pursuant to the completion of audit. JHSGP will submit an action plan on the observations


FDA approves Lenire device by Neuromod for tinnitus treatment option for US veterans
Medical Device | June 19, 2024

FDA approves Lenire device by Neuromod for tinnitus treatment option for US veterans

Lenire is the first and only bimodal neuromodulation device to be awarded a Federal Supply Schedule (FSS) Contract from the US Government


Alembic announces USFDA final approval for Icatibant injection
Drug Approval | June 17, 2024

Alembic announces USFDA final approval for Icatibant injection

This is the first peptide product approval from the USFDA received by Alembic Pharmaceuticals


Jubilant Draximage to invest US$ 50 million to expand its PET radiopharmacy network
News | June 15, 2024

Jubilant Draximage to invest US$ 50 million to expand its PET radiopharmacy network

Jubilant's Radiopharma Business to expand positron emission tomography radiopharmacy network


Jubilant Pharmova announces voluntary prepayment of US$ 75 million term loan
News | June 15, 2024

Jubilant Pharmova announces voluntary prepayment of US$ 75 million term loan

As on 31st March 2024, Jubilant Pharmova Limited reported Gross Debt at Rs. 3,414 crore