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Results For "marketing-authorization"

199 News Found

Venus Remedies secures marketing authorization from UK MHRA for Cisplatin
News | April 27, 2023

Venus Remedies secures marketing authorization from UK MHRA for Cisplatin

Company intends to increase sales in the UK to approximately 2 million Euros by focusing on seven molecules which are already registered in the country


EMA recommends refusal of the marketing authorization for Lagevrio
News | February 25, 2023

EMA recommends refusal of the marketing authorization for Lagevrio

Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP’s opinion.


CHMP recommends conditional marketing authorization for Spesolimab for generalized pustular psoriasis flares
News | October 17, 2022

CHMP recommends conditional marketing authorization for Spesolimab for generalized pustular psoriasis flares

CHMP positive opinion is based on evidence from the EFFISAYIL trial, the largest clinical trial in


BridgeBio Pharma, Sentynl Therapeutics receive marketing authorization in the EU for fosdenopterin
Drug Approval | September 22, 2022

BridgeBio Pharma, Sentynl Therapeutics receive marketing authorization in the EU for fosdenopterin

NULIBRY is a first-in-class cPMP substrate replacement therapy to reduce the risk of mortality in patients with MoCD Type A.


Moderna to become marketing authorization holder in Japan for Spikevax
News | June 01, 2022

Moderna to become marketing authorization holder in Japan for Spikevax

Companies concluded memorandum of understanding that Takeda will continue to provide distribution support for the Moderna COVID-19 vaccines for a transitional period


Japan okays new long-acting eye drug
News | March 24, 2026

Japan okays new long-acting eye drug

It promises fewer injections for vision loss patients


Sun Pharma scores FDA review for ILUMYA in psoriatic arthritis
News | March 18, 2026

Sun Pharma scores FDA review for ILUMYA in psoriatic arthritis

ILUMYA has already earned FDA approvals for scalp and nail plaque psoriasis in April 2024 and December 2025


Zuellig Pharma expands Cialis footprint across Asia
News | March 16, 2026

Zuellig Pharma expands Cialis footprint across Asia

The expanded ownership is expected to improve access to Cialis for millions of men in Asia affected by ED and BPH


Veristat expands global trial & regulatory services as Chinese drugmakers push overseas
Clinical Trials | March 14, 2026

Veristat expands global trial & regulatory services as Chinese drugmakers push overseas

The expansion builds on Veristat’s work helping Chinese pharmaceutical firms such as Hansoh Pharma and CStone Pharmaceuticals


Sumitomo Pharma bags world-first go-ahead for iPS cell therapy to treat Parkinson’s disease
News | March 10, 2026

Sumitomo Pharma bags world-first go-ahead for iPS cell therapy to treat Parkinson’s disease

The conditional, time-limited approval comes through a joint effort with RACTHERA, a joint venture in which Sumitomo Chemical holds a 66.6% stake and Sumitomo Pharma holds 33.4%