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Satsuma Migraine Resubmitted NDA Approved

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FDA approves a Satsuma Pharmaceuticals 505(b)(2) NDA for Atzumi (dihydroergotamine (DHE)) nasal powder for the acute treatment of ...

FDA OKs J&Js Imaavy for Myasthenia Gravis

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FDA approves a Johnson & Johnson BLA for Imaavy (nipocalimab-aahu) for treating generalized myasthenia gravis.

Unanimous SCOTUS Decision Reassuring: Post

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George Washington University law professor Richard Pierce praises a recent unanimous Supreme Court decision backing FDA in an e-ci...

Boehringer Drug Shows Encouraging Data in Lung Cancer

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Boehringer Ingelheim releases new findings from its Beamion LUNG-1 trial, highlighting the potential of zongertinib as a breakthro...

Reopen FDA San Juan Lab: Representatives

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Reps. Alexandria Orcasio-Cortez and Nydia Velzquez ask HHS secretary Robert F. Kennedy, Jr., to reopen the FDA San Juan medical pr...

Immunic Reports Positive Data on MS Drug

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Immunic reports positive data from its Phase 2 CALLIPER trial of nuclear receptor related 1 activator vidofludimus calcium (IMU-83...

Gilead Pays $202 Million Over Kickbacks Scheme

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Gilead Sciences agrees to pay $202 million to resolve claims that the company offered and paid kickbacks (e.g., honoraria payments...

Makary Suggests Raising Bar on Covid Boosters

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FDA commissioner Marty Makary suggests more data could be required for Covid-19 vaccine boosters this winter.

Little Trust in New Health Leaders: Poll

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A poll from the Harvard University T.H. Chan School of Public Health finds that more Americans say they will be trusting public he...

FDA Layoffs Affect Product Development: Post

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Skadden attorneys say the FDA reduction in force should have the greatest negative impact on products that are in development.