Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 2

Results For "US-Food-and-Drug-Administration"

212 News Found

FDA clears Cercare Medical’s CBCT perfusion technology for real-time stroke imaging
Medical Device | June 01, 2026

FDA clears Cercare Medical’s CBCT perfusion technology for real-time stroke imaging

The technology enables clinicians to assess brain tissue and microvascular reperfusion directly in the angiography suite, potentially improving stroke treatment decisions and patient outcomes


Abbott secures CE mark for first dual glucose-ketone monitoring systems
Medical Device | May 29, 2026

Abbott secures CE mark for first dual glucose-ketone monitoring systems

Libre Duo devices become the first glucose-ketone monitors approved for diabetes care, offering real-time alerts for diabetic ketoacidosis risk


Astrazeneca’s Baxfendy wins US approval as first-in-class hypertension drug
Drug Approval | May 19, 2026

Astrazeneca’s Baxfendy wins US approval as first-in-class hypertension drug

Baxfendy works in a fundamentally different way from current therapies


Cipla achieves highest-ever annual revenue of Rs. 28,163 crore in FY26
News | May 15, 2026

Cipla achieves highest-ever annual revenue of Rs. 28,163 crore in FY26

The company witnesses strong growth across its India, Africa, and emerging markets businesses, while securing regulatory approval for the first AB-rated gVentolin in the U.S. market


FDA clears Rivanna’s Accuro XV AI-powered 3D ultrasound system
Medical Device | May 11, 2026

FDA clears Rivanna’s Accuro XV AI-powered 3D ultrasound system

The ultrasound-based AI imaging platform is designed to support rapid fracture detection and soft tissue injury assessment in emergency care settings


Moderna’s mRNA flu vaccine outperforms standard shot in Phase 3 trial
Clinical Trials | May 08, 2026

Moderna’s mRNA flu vaccine outperforms standard shot in Phase 3 trial

NEJM study shows strong protection across strains


Alkem Laboratories receives 7 observations following US FDA inspection at Daman facility
Drug Approval | May 04, 2026

Alkem Laboratories receives 7 observations following US FDA inspection at Daman facility

The US regulator conducted an inspection at the Amaliya manufacturing plant between April 20 and May 1, 2026


FDA advisory panel backs AstraZeneca prostate cancer combo in decisive vote
News | May 04, 2026

FDA advisory panel backs AstraZeneca prostate cancer combo in decisive vote

The Committee backed the combination based on results from the CAPItello-281 Phase III trial, marking a key milestone in the regulatory pathway for AstraZeneca’s targeted therapy strategy in prostate cancer


FDA okays AstraZeneca’s triple therapy Breztri for asthma
Medical Device | April 29, 2026

FDA okays AstraZeneca’s triple therapy Breztri for asthma

The aim is to simplify and strengthen long-term control of airway disease through triple therapy in one device