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3331 News Found

TAHO Pharma submits NDA to FDA for world’s first Apixaban oral dissolving film
News | October 06, 2025

TAHO Pharma submits NDA to FDA for world’s first Apixaban oral dissolving film

Pioneering innovation aims to transform anticoagulant therapy and improve patient outcomes


Teva unveils promising SOLARIS resultsfor Olanzapine LAI
Clinical Trials | September 23, 2025

Teva unveils promising SOLARIS resultsfor Olanzapine LAI

No post-injection Delirium/Sedation Syndrome (PDSS) observed through 56 weeks


FDA completes inspection of Indoco’s API manufacturing facility at Patalganga with zero observations
Drug Approval | September 19, 2025

FDA completes inspection of Indoco’s API manufacturing facility at Patalganga with zero observations

The inspection concluded with zero form 483 observations


Alembic Pharmaceuticals receives EIR for API - I and API - II facility located at Panelav
News | September 16, 2025

Alembic Pharmaceuticals receives EIR for API - I and API - II facility located at Panelav

The inspection was carried out between May 26, 2025 and May 31, 2025


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


Apitoria Pharma receives 5 observations from USFDA for API facility
Drug Approval | August 31, 2025

Apitoria Pharma receives 5 observations from USFDA for API facility

At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported


AbbVie to invest $195 million to expand API manufacturing in North Chicago
News | August 16, 2025

AbbVie to invest $195 million to expand API manufacturing in North Chicago

The new facility will enhance AbbVie’s chemical synthesis capacity to support domestic production of current and next-generation neuroscience, immunology, and oncology medicines


Bristol Myers Squibb and Bain Capital launch biotech company NewCo
News | July 31, 2025

Bristol Myers Squibb and Bain Capital launch biotech company NewCo

NewCo’s pipeline includes five investigational medicines