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Results For "authorization"

327 News Found

ZIM Laboratories and Neuraxpharm granted marketing authorization for Buprenorphine Sublingual Film in Europe
News | January 10, 2025

ZIM Laboratories and Neuraxpharm granted marketing authorization for Buprenorphine Sublingual Film in Europe

According to IQVIA, the European market for Buprenorphine-based opioid dependency treatments in 2023 surpassed USD 355 million annually


Pfizer and BioNTech receive FDA authorization for Omicron KP.2-adapted Covid-19 Vaccine
Drug Approval | August 23, 2024

Pfizer and BioNTech receive FDA authorization for Omicron KP.2-adapted Covid-19 Vaccine

The updated COVID-19 vaccine is tailored to the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage and is recommended for individuals 6 months of age and older


UK Relonchem receives marketing authorization for Levonorgestrel 1.5 mg Tablets
News | August 06, 2024

UK Relonchem receives marketing authorization for Levonorgestrel 1.5 mg Tablets

Relonchem Limited has received Marketing Authorization for the product Levonorgestrel 1.5 mg Tablets from UK MHRA


Sentynl Therapeutics receives marketing authorization for Nulibry from UK MHRA
Drug Approval | April 22, 2024

Sentynl Therapeutics receives marketing authorization for Nulibry from UK MHRA

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


Venus Remedies obtains marketing authorizations for essential oncology drugs in Ukraine
Drug Approval | March 09, 2024

Venus Remedies obtains marketing authorizations for essential oncology drugs in Ukraine

These approvals mark significant progress for Venus Remedies in expanding its market presence


CuraTeQ Biologics receives recommendation for grant of marketing authorization of 'biosimilar trastuzumab'
News | January 17, 2024

CuraTeQ Biologics receives recommendation for grant of marketing authorization of 'biosimilar trastuzumab'

Trastuzumab biosimilar is a humanized monoclonal antibody for treating metastatic breast cancer


Venus Remedies granted market authorizations in Saudi Arabia and Philippines
News | December 02, 2023

Venus Remedies granted market authorizations in Saudi Arabia and Philippines

These regulatory approvals signify a significant milestone for Venus Remedies Limited


Sumitomo Pharma announces authorization in Canada of Orgovyx for treatment prostate cancer
News | October 25, 2023

Sumitomo Pharma announces authorization in Canada of Orgovyx for treatment prostate cancer

Orgovyx is the first and only oral GnRH receptor antagonist approved for advanced prostate cancer in Canada


Novavax's Nuvaxovid receives full marketing authorization in the EU
News | July 10, 2023

Novavax's Nuvaxovid receives full marketing authorization in the EU

Marketing Authorization replaces conditional Marketing Authorization and is first for Novavax in the EU


Moderna files for FDA authorization of its Covid-19 Vaccine
Drug Approval | June 27, 2023

Moderna files for FDA authorization of its Covid-19 Vaccine

Supply readiness follows months of manufacturing to ensure timely and ample supply