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Results For "regulators"

159 News Found

LENZ Therapeutics, Lotus Pharmaceutical submit NDA for presbyopia treatment in Korea
Drug Approval | December 03, 2025

LENZ Therapeutics, Lotus Pharmaceutical submit NDA for presbyopia treatment in Korea

Presbyopia, the age-related loss of near vision, could soon be treated successfully


Bayer welcomes US Solicitor General’s support as Supreme Court weighs Roundup case
News | December 02, 2025

Bayer welcomes US Solicitor General’s support as Supreme Court weighs Roundup case

At the heart of the showdown is a deep split among federal circuit courts over whether federal law overrides state failure-to-warn claims in Roundup personal-injury suits


India’s pharma industry showcases innovation, global ambitions at CPHI & PMEC India 2025
News | November 27, 2025

India’s pharma industry showcases innovation, global ambitions at CPHI & PMEC India 2025

India's pharmaceutical sector is rapidly shifting from a generics-led foundation to an innovation-driven ecosystem


Novo Nordisk fast-tracks higher-dose obesity drug to FDA
Clinical Trials | November 27, 2025

Novo Nordisk fast-tracks higher-dose obesity drug to FDA

The drug, intended for chronic weight management alongside diet and exercise, is now under the FDA’s new CNPV expedited review pathway


Shilpa Medicare receives 8 observations from USFDA for Unit 4 at Jadcherla
Drug Approval | November 24, 2025

Shilpa Medicare receives 8 observations from USFDA for Unit 4 at Jadcherla

The Unit is approved by major regulators like EMA, Europe; Health Canada, Anvisa, Brazil and TGA, Australia


Industry leaders call for a new era of collaboration, innovation, and self-reliance
News | November 03, 2025

Industry leaders call for a new era of collaboration, innovation, and self-reliance

Building a transparent, data-driven supply chain and self-reliant API ecosystem remains critical to reducing import dependence


Moderna delivers Canada’s first locally manufactured mRNA vaccines
News | September 23, 2025

Moderna delivers Canada’s first locally manufactured mRNA vaccines

All drug substance for Moderna’s authorized Spikevax (COVID-19 mRNA vaccine) targeting the SARS-CoV-2 LP.8.1 variant is produced at the company’s facility in Laval, Quebec


AstraZeneca's Saphnelo succeeds in Phase III as self-injectable lupus treatment
Clinical Trials | September 18, 2025

AstraZeneca's Saphnelo succeeds in Phase III as self-injectable lupus treatment

The TULIP-SC trial investigated the efficacy and safety of subcutaneous Saphnelo


iPHEX 2025: Piyush Goyal calls for deeper global collaborations to strengthen healthcare systems worldwide
Healthcare | September 05, 2025

iPHEX 2025: Piyush Goyal calls for deeper global collaborations to strengthen healthcare systems worldwide

Goyal reaffirmed the government’s commitment to facilitating market access, reducing trade barriers, and ensuring that Indian exporters remain globally competitive


iPHEX 2025: Global regulatory conclaves to highlight India’s role in shaping global health
News | September 03, 2025

iPHEX 2025: Global regulatory conclaves to highlight India’s role in shaping global health

This year’s edition will witness participation of over 700 Indian exporters showcasing their products and services; 500+ overseas delegates representing more than 120 countries; 20,000 domestic visitors; and 8,000+ B2B meetings