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FDA announces crackdown on ‘misleading’ DTC pharmaceutical ads
11 Sep 2025 01:29 GMT
… prescription drug advertising.”
The FDA announced it plans to crackdown … prices for everyday Americans.”
The FDA release also referenced therapies promoted … AbbVie, Artax, Bristol Myers Squibb, Boehringer Ingelheim, Celldex, Eli Lilly, FIDE, GlaxoSmithKline …
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How a change in FDA guidance might revolutionise MASH drug development
10 Sep 2025 08:24 GMT
… review by the FDA. After this, the FDA issues another … responded positively to the FDA decision. Echosens has noted … that it had joined Boehringer Ingelheim and Novo Nordisk in … double down their efforts towards FDA acceptance.
Nevertheless, Echosens could …
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<![CDATA[FDA Accepts FibroScan Letter of Intent for Surrogate Endpoint in MASH Trials]]>
09 Sep 2025 14:48 GMT
… Food and Drug Administration (FDA)’s Center for Drug Evaluation … of support from Eli Lilly, Boehringer Ingelheim, and Novo Nordisk, LSM … (Wegovy) are the only FDA-approved treatments for MASH, both … trials.1
"The FDA accepting this letter of intent …
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China NMPA approves Boehringer Ingelheim's Hernexeos as first oral targeted therapy for previously treated patients with HER2─mutant advanced NSCLC
02 Sep 2025 07:35 GMT
… board of managing directors at Boehringer Ingelheim. “Given the robust clinical evidence … been approved by the US FDA (as Hernexeos) and China’s … personal, today and for generations.
Boehringer Ingelheim is a biopharmaceutical company active …
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Zongertinib Receives FDA Breakthrough Therapy Designation in Nonsquamous NSCLC With HER2 TKD Mutations
04 Sep 2025 21:29 GMT
… in this cohort.
References
FDA grants HERNEXEOS breakthrough therapy designation … mutant advanced NSCLC. News release. Boehringer Ingelheim. September 3, 2025. Accessed September … -information-approved-drugs/fda-grants-accelerated-approval-zongertinib-non …
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Insmed scores pivotal win in bronchiectasis with FDA approval of Brinsupri
04 Sep 2025 13:01 GMT
… US Food and Drug Administration (FDA) approval of Insmed’s Brinsupri … in development for bronchiectasis, including Boehringer Ingelheim’s BI-1291583, Haisco Pharmaceutical … market in 2033. Brinsupri’s FDA approval is also a pivotal …
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FDA Grants Breakthrough Therapy Designation to Zongertinib Tablets in NSCLC
04 Sep 2025 00:12 GMT
… line of systemic therapy.6
FDA grants HERNEXEOS® Breakthrough Therapy Designation … TKD activating mutations. News release. FDA. August 8, 2025. Accessed September … mutant advanced NSCLC. News release. Boehringer Ingelheim. September 1, 2025. Accessed September …
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FDA Grants BTD to Zongertinib, Marks New Frontier for HER2+ NSCLC
03 Sep 2025 16:02 GMT
… [zongertinib].”
Last month, the FDA granted accelerated approval to zongertinib … contact us.
REFERENCES:
1. FDA grants HERNEXEOS® Breakthrough Therapy Designation … mutant advanced NSCLC. News release. Boehringer Ingelheim. September 3, 2025. Accessed …
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FDA grants HERNEXEOS® Breakthrough Therapy Designation for first line use in HER2 (ERBB2)-mutant advanced NSCLC
03 Sep 2025 15:12 GMT
… Food and Drug Administration (FDA) for first-line treatment … by the U.S. FDA for adult patients with … , as detected by an FDA-approved test, and who … and for generations.
About Boehringer Ingelheim
Boehringer Ingelheim is a biopharmaceutical company active …
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Every Oncologic FDA Approval Throughout August 2025
03 Sep 2025 01:31 GMT
… and progression-free survival.
FDA Grants Accelerated Approval to Hernexeos …
According to the biopharmaceutical company Boehringer Ingelheim, Hernexeos may represent the first … limited targeted treatment approaches.
FDA Approves Modeyso for Rare Pediatric …