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

Results For "(FDA"

661 News Found

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


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 renews IQOS “reduced-risk” status backing PMI’s smoke-free strategy in regulatory win
News | May 02, 2026

FDA renews IQOS “reduced-risk” status backing PMI’s smoke-free strategy in regulatory win

The renewal covers two versions of the IQOS device and three HEETS tobacco variants


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


Essilor Stellest lens positioned as key breakthrough in myopia control in India
News | April 28, 2026

Essilor Stellest lens positioned as key breakthrough in myopia control in India

The lens received U.S. Food and Drug Administration (FDA) market authorization via the De Novo pathway in late 2025


EssilorLuxottica receives FDA authorization for its Essilor Stellest lens for myopia control
Medical Device | April 28, 2026

EssilorLuxottica receives FDA authorization for its Essilor Stellest lens for myopia control

The company plans a phased expansion across India, focusing initially on metro cities and early-adoption hubs


Philips bags FDA nod for next-gen CT platform
Medical Device | April 24, 2026

Philips bags FDA nod for next-gen CT platform

Aims to boost speed & precision in patient care


Astellas & Pfizer win FDA priority review for bladder cancer treatment expansion
News | April 22, 2026

Astellas & Pfizer win FDA priority review for bladder cancer treatment expansion

A decision is expected by August 17, 2026 under the Prescription Drug User Fee Act timeline


Orbicular's partner secures tentative U.S. ANDA approval for a generic version of Ozempic
Drug Approval | April 21, 2026

Orbicular's partner secures tentative U.S. ANDA approval for a generic version of Ozempic

OneSource is the contract development and manufacturing organization (CDMO) partner for this product