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Results For "regulatory-win"

14 News Found

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


WuXi Biologics wins fourth EMA certification for Suzhou Biosafety Center
News | June 23, 2026

WuXi Biologics wins fourth EMA certification for Suzhou Biosafety Center

Clearing 19 biologics for Europe market


Alembic secures USFDA nod for Tretinoin Cream strengthening generics portfolio
Drug Approval | June 14, 2026

Alembic secures USFDA nod for Tretinoin Cream strengthening generics portfolio

The approval clears the company to market a generic version that is therapeutically equivalent to Retin-A Cream


Bristol Myers Squibb wins EU approval for Opdivo-based frontline treatment in advanced hodgkin lymphoma
Drug Approval | June 02, 2026

Bristol Myers Squibb wins EU approval for Opdivo-based frontline treatment in advanced hodgkin lymphoma

The approval is supported by results from the Phase 3 SWOG 1826 trial


ZIM Laboratories wins European regulatory milestone with anticoagulant approval in Italy
News | May 23, 2026

ZIM Laboratories wins European regulatory milestone with anticoagulant approval in Italy

The approval was granted by Agenzia Italiana del Farmaco


Bristol Myers Squibb wins EU nod for Sotyktu in active psoriatic arthritis
Drug Approval | May 11, 2026

Bristol Myers Squibb wins EU nod for Sotyktu in active psoriatic arthritis

The once-daily oral therapy is the first and only tyrosine kinase 2 (TYK2) inhibitor approved in the European Union for this indication, marking a significant expansion of its immunology portfolio


Merck posts mixed Q1 2026 results as blockbuster drugs drive growth
News | May 02, 2026

Merck posts mixed Q1 2026 results as blockbuster drugs drive growth

But acquisition charges drag earnings into loss


Aurobindo Pharma wins key FDA nod for $138M US cough drug market entry
Drug Approval | April 20, 2026

Aurobindo Pharma wins key FDA nod for $138M US cough drug market entry

The drug is designed to provide temporary relief from cough caused by throat and bronchial irritation


Lupin scores major US breakthrough with FDA nod for key diabetes drug
Drug Approval | April 10, 2026

Lupin scores major US breakthrough with FDA nod for key diabetes drug

The Abbreviated New Drug Application with FDA covers multiple strengths of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets