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Browsing Tag

FDA

17 posts
EEurope
Hansa CEO Aguiar-Lucander: U.S. Listing Is Not Optional for European Biotech — BigGo Finance
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Hansa CEO Aguiar-Lucander: U.S. Listing Is Not Optional for European Biotech — BigGo Finance

  • September 2, 2026
For the roughly 20% of kidney transplant candidates considered highly sensitized, the odds of receiving a compatible organ…
EEU
GILD Stock Garners Retail Attention On Trodelvy EU Approval Ahead Of August 27 HIV FDA Verdict
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GILD Stock Garners Retail Attention On Trodelvy EU Approval Ahead Of August 27 HIV FDA Verdict

  • August 24, 2026
Expanding Trodelvy into the first-line setting strengthens Gilead’s oncology franchise, which has been growing alongside its dominant HIV…
EEU
9 Foods Americans Eat That Face Stricter EU Rules
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9 Foods Americans Eat That Face Stricter EU Rules

  • August 16, 2026
The difference between U.S. and EU food rules is not as simple as one side allowing something the…
EEuropean Commission
THOUSAND OAKS CALIFORNIA - 17 Amgen logo
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Drug Trial Data Manipulation Wiped Avacopan’s EU Approval as FDA Hearing Looms

  • August 14, 2026
When regulators at the European Medicines Agency published the full scientific rationale behind Europe’s withdrawal of avacopan on…
EEurope
European Medicines Agency Expedites Assessment of Revolution Medicines’ Daraxonrasib Under Phased Review Process
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European Medicines Agency Expedites Assessment of Revolution Medicines’ Daraxonrasib Under Phased Review Process

  • July 7, 2026
Revolution Medicines, Inc. REDWOOD CITY, Calif., July 07, 2026 (GLOBE NEWSWIRE) — Revolution Medicines, Inc. (Nasdaq: RVMD), a…
EEurope
European Medicines Agency Expedites Assessment of Revolution Medicines’ Daraxonrasib Under Phased Review Process
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European Medicines Agency Expedites Assessment of Revolution Medicines’ Daraxonrasib Under Phased Review Process

  • July 7, 2026
Revolution Medicines, Inc. REDWOOD CITY, Calif., July 07, 2026 (GLOBE NEWSWIRE) — Revolution Medicines, Inc. (Nasdaq: RVMD), a…
EEU
EU regulator backs revoking Amgen's right to sell rare-disease drug
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EU regulator backs revoking Amgen’s right to sell rare-disease drug

  • June 26, 2026
By Christy Santhosh June 26 (Reuters) – Europe’s drug regulator on Friday recommended revoking the marketing authorization for…
EEurope
Omeros Corporation Announces Update on European Marketing Authorization Application for Narsoplimab in TA-TMA
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Omeros Corporation Announces Update on European Marketing Authorization Application for Narsoplimab in TA-TMA

  • June 26, 2026
SEATTLE, June 26, 2026–(BUSINESS WIRE)–Omeros Corporation (Nasdaq: OMER) announced today an update on the review by the Committee…
EEurope
A better sunscreen has been available in Europe for 25 years. It just became legal to sell in the U.S.
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A better sunscreen has been available in Europe for 25 years. It just became legal to sell in the U.S.

  • June 21, 2026
On June 9, 2026, the U.S. Food and Drug Administration approved the first new sunscreen ingredient to be…
EEurope
FDA approves sunscreen ingredient used for decades in Europe, Asia
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FDA approves sunscreen ingredient used for decades in Europe, Asia

  • June 10, 2026
Americans soon will have access to more sunscreen containing a more effective ingredient that has been available in…
EEurope
FDA Approved First New Sunscreen Ingredient Since 1999
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FDA Approved First New Sunscreen Ingredient Since 1999

  • June 10, 2026
You no longer have to haul French sunscreens home from your vacation — or pay exorbitant shipping fees…
EEU
Agri-Pulse Newsmakers: Farm aid, USMCA review, EU deforestation regs with Rep. Austin Scott
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Agri-Pulse Newsmakers: Farm aid, USMCA review, EU deforestation regs with Rep. Austin Scott

  • May 15, 2026
Stay in the loop for upcoming Agri-Pulse webinars and events! Join our mailing list here: http://eepurl.com/iIjchw Agri-Pulse and Agri-Pulse…
Europe
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