Tag: European Commission

Advancing Bone Health: European Commission Approves Biocon Biologics’ Denosumab Biosimilars

BENGALURU, India, July 3, 2025 /PRNewswire/ -- Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd., today announced that...

Weather RADAR Market Set to Hit Valuation of US$ 816.19 Million By 2033 | Astute Analytica

CHICAGO, July 2, 2025 /PRNewswire/ -- The global weather RADAR market was valued at US$ 158.43 million in 2024 and is projected to reach US$...

Weather RADAR Market Set to Hit Valuation of US$ 816.19 Million By 2033 | Astute Analytica

CHICAGO, July 2, 2025 /PRNewswire/ -- The global weather RADAR market was valued at US$ 158.43 million in 2024 and is projected to reach US$...

GlucoModicum Reports Positive Clinical Results with its Needle-Free CGM and Advances Toward Market Launch

GlucoModicum Reports Positive Clinical Results with its Needle-Free CGM and Advances Toward Market Launch

New ECCIA-Bain report: Europe’s high-end sector sounds alarm on tariffs, skills and competitiveness

New Report on Europe's High-End Sector Shows €986 Billion Economic Engine Powerhouse Driving Jobs, Tourism & Craftsmanship Projected global high-end & luxury market growth expected...

New ECCIA-Bain report: Europe’s high-end sector sounds alarm on tariffs, skills and competitiveness

New Report on Europe's High-End Sector Shows €986 Billion Economic Engine Powerhouse Driving Jobs, Tourism & Craftsmanship Projected global high-end & luxury market growth expected...

Jazz Pharmaceuticals Receives European Commission Marketing Authorization for Ziihera® (zanidatamab) for the Treatment of Advanced HER2-Positive Biliary Tract Cancer

– Conditional approval based on positive results from the HERIZON-BTC-01 Phase 2b trial – DUBLIN, July 1, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ)...

Cancer Therapeutics Market Forecast to Reach $168 Billion by 2029, Highlighting Recurrent and Metastatic Innovations

"Metastatic Cancer: A Significant Therapeutic Challenge as Pharmaceutical Companies Leverage Digital Platforms and Data to Enhance Engagement with Patients, Providers, and Regulators in the...

Launch of EU co-funded Campaign promoting high-quality European and Italian Canned Tomatoes in the UK

NAPLES, Italy, June 27, 2025 /PRNewswire/ -- ANICAV - The Italian Association of Canned Vegetables Industries - proudly announces the launch of its promotional...

Novo Nordisk A/S: Ozempic® receives EU recommendation in peripheral arterial disease, cementing the broad benefits of semaglutide for people with type 2 diabetes and...

Bagsværd, Denmark, 23 June 2025 – Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Ozempic^® (once-weekly semaglutide) label to reflect the positive data from the STRIDE peripheral artery disease (PAD) functional outcomes trial.

Sephience™ (sepiapterin) Granted Marketing Authorization by the European Commission for the Treatment of Children and Adults Living with Phenylketonuria (PKU)

– Broad label inclusive of all ages and disease severities – – Launch to be initiated in Germany – WARREN, N.J., June 23, 2025 /PRNewswire/ -- PTC Therapeutics, Inc....

European Medicines Agency Recommends Market Approval of AVT06, Alvotech’s Proposed Biosimilar to Eylea® (aflibercept)

REYKJAVIK, Iceland and LONDON, June 23, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) adopted a positive opinion recommending approval for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept 2 mg). Based on a positive recommendation by CHMP, biosimilar medicines can be approved by the European Commission for marketing in the European Economic Area, that includes the 27 member states of the European Union, in addition to Norway, Iceland and Lichtenstein.

European Medicines Agency Recommends Market Approval of AVT06, Alvotech’s Proposed Biosimilar to Eylea® (aflibercept)

REYKJAVIK, ICELAND and LONDON, UK (June 23, 2025) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) adopted a positive opinion recommending approval for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept 2 mg). Based on a positive recommendation by CHMP, biosimilar medicines can be approved by the European Commission for marketing in the European Economic Area, that includes the 27 member states of the European Union, in addition to Norway, Iceland and Lichtenstein.

New data demonstrates robust efficacy of Vyepti® (eptinezumab) in otherwise difficult-to-treat patients with severe migraine

The full results of the phase IV RESOLUTION trial were presented at the European Academy of Neurology 2025 Annual Congress, where Vyepti® (eptinezumab) demonstrated...

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HomeTagsEuropean Commission

Decision Notice – CIRO Hearing Panel issues its Reasons for Decision in the matter of Scott Nicolas Zurevinski

The Wait is Over: Hard Rock Hotel & Casino Ottawa Opens with Legendary Guitar Smash and Star-Studded Celebration

BAYOTECH SHIFTS NORTHERN CALIFORNIA HYDROGEN HUB DEVELOPMENT TO NEW SITE TO ACCELERATE IMPACT

Tag: European Commission

Advancing Bone Health: European Commission Approves Biocon Biologics’ Denosumab Biosimilars

Weather RADAR Market Set to Hit Valuation of US$ 816.19 Million By 2033 | Astute Analytica

Weather RADAR Market Set to Hit Valuation of US$ 816.19 Million By 2033 | Astute Analytica

GlucoModicum Reports Positive Clinical Results with its Needle-Free CGM and Advances Toward Market Launch

New ECCIA-Bain report: Europe’s high-end sector sounds alarm on tariffs, skills and competitiveness

New ECCIA-Bain report: Europe’s high-end sector sounds alarm on tariffs, skills and competitiveness

Jazz Pharmaceuticals Receives European Commission Marketing Authorization for Ziihera® (zanidatamab) for the Treatment of Advanced HER2-Positive Biliary Tract Cancer

Cancer Therapeutics Market Forecast to Reach $168 Billion by 2029, Highlighting Recurrent and Metastatic Innovations

Launch of EU co-funded Campaign promoting high-quality European and Italian Canned Tomatoes in the UK

Novo Nordisk A/S: Ozempic® receives EU recommendation in peripheral arterial disease, cementing the broad benefits of semaglutide for people with type 2 diabetes and...

Sephience™ (sepiapterin) Granted Marketing Authorization by the European Commission for the Treatment of Children and Adults Living with Phenylketonuria (PKU)

European Medicines Agency Recommends Market Approval of AVT06, Alvotech’s Proposed Biosimilar to Eylea® (aflibercept)

European Medicines Agency Recommends Market Approval of AVT06, Alvotech’s Proposed Biosimilar to Eylea® (aflibercept)

New data demonstrates robust efficacy of Vyepti® (eptinezumab) in otherwise difficult-to-treat patients with severe migraine

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