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Results For "regulatory"

1428 News Found

SMS Pharmaceuticals receives EIR from USFDA for Central Laboratory Analytical Services
News | August 27, 2025

SMS Pharmaceuticals receives EIR from USFDA for Central Laboratory Analytical Services

The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations


Dr. Reddy's launches novel drug for chronic constipation management
News | August 26, 2025

Dr. Reddy's launches novel drug for chronic constipation management

Dr. Reddy’s becomes the first pharmaceutical company to receive regulatory approval to launch Linaclotide in India under the brand name Colozo


Remedium Lifecare charts 4X growth strategy
News | August 26, 2025

Remedium Lifecare charts 4X growth strategy

The first pillar is advanced manufacturing, focused on upgrading existing CDMO


CuraTeQ Biologics receives approval for biosimilar Dazublys from UK's MHRA
News | August 26, 2025

CuraTeQ Biologics receives approval for biosimilar Dazublys from UK's MHRA

Earlier in July 2025, Dazublys has received the marketing authorisation in the European Union from the European Commission


Boehringer and AnGes sign manufacturing agreement for HGF gene therapy product
Biotech | August 25, 2025

Boehringer and AnGes sign manufacturing agreement for HGF gene therapy product

Collaboration reinforces Boehringer Ingelheim’s expertise in microbial contract development and manufacturing


Corbion and Kuehnle join forces to develop natural Astaxanthin from algae fermentation
Biotech | August 23, 2025

Corbion and Kuehnle join forces to develop natural Astaxanthin from algae fermentation

Astaxanthin is a powerful antioxidant and red-orange carotenoid pigment found in various aquatic organisms


Moderna receives Health Canada approval for updated COVID-19 vaccine targeting SARS-CoV-2 Variant LP.8.1
Drug Approval | August 23, 2025

Moderna receives Health Canada approval for updated COVID-19 vaccine targeting SARS-CoV-2 Variant LP.8.1

All 2025 pre-filled syringe doses to be made in Canada, marking a domestic production milestone


AbbVie announces positive topline results from second Phase 3 UP-AA trial evaluating Upadacitinib
News | August 23, 2025

AbbVie announces positive topline results from second Phase 3 UP-AA trial evaluating Upadacitinib

The safety profile in alopecia areata was generally consistent with that in approved indications, and no new safety signals were identified in this study