Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 6

Results For "Food-and-Drug-Administration"

1066 News Found

Innoxel Lifesciences completes USFDA inspection
Drug Approval | May 06, 2025

Innoxel Lifesciences completes USFDA inspection

This outcome reflects Innoxel Lifesciences' ongoing commitment to maintaining the highest standards of quality, compliance, and regulatory excellence


Neuland Laboratories completes USFDA inspection at Unit 2
Drug Approval | May 03, 2025

Neuland Laboratories completes USFDA inspection at Unit 2

The FDA issued Form 483 with one observation related to building and facility management


Zydus receives final approval from USFDA for Niacin Extended-Release Tablets USP
Drug Approval | May 02, 2025

Zydus receives final approval from USFDA for Niacin Extended-Release Tablets USP

Niacin is indicated to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B and triglycerides (TG)


Gland Pharma receives USFDA approval for Latanoprostene Bunod Ophthalmic Solution
Drug Approval | May 01, 2025

Gland Pharma receives USFDA approval for Latanoprostene Bunod Ophthalmic Solution

This Product is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension


Lupin receives USFDA approval for Tolvaptan Tablets
Drug Approval | April 24, 2025

Lupin receives USFDA approval for Tolvaptan Tablets

Tolvaptan is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease


Caplin Steriles gets USFDA approval for Phytonadione Injectable Emulsion
Drug Approval | April 24, 2025

Caplin Steriles gets USFDA approval for Phytonadione Injectable Emulsion

Phytonadione Injectable Emulsion possesses the same type and degree of activity as does naturally-occurring vitamin K


FDA approves Medtronic’s new Simplera Sync sensor for the MiniMed 780G system
Drug Approval | April 21, 2025

FDA approves Medtronic’s new Simplera Sync sensor for the MiniMed 780G system

The Simplera Sync is a disposable, all-in-one sensor that requires no fingersticks with SmartGuard


ACIP votes to expand recommendation for Pfizer’s RSV vaccine ABRYSVO to include adults aged 50 – 59 at increased risk of disease
News | April 17, 2025

ACIP votes to expand recommendation for Pfizer’s RSV vaccine ABRYSVO to include adults aged 50 – 59 at increased risk of disease

Vote expands existing recommendation, which was for all adults aged 75 and older and high-risk adults aged 60 to 74


Lupin receives EIR from USFDA for its injectable facility in Nagpur
Drug Approval | April 17, 2025

Lupin receives EIR from USFDA for its injectable facility in Nagpur

The EIR was issued following an inspection of the facility conducted from June 10 to June 13, 2024


Biocon Biologics secures market entry date for Yesafili in US
News | April 15, 2025

Biocon Biologics secures market entry date for Yesafili in US

YESAFILI, a vascular endothelial growth factor (VEGF) inhibitor, is used to treat several different types of ophthalmology conditions