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Mercks Winrevair Sees Phase 2 Pulmonary Hypertension Win

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Merck reports that its drug Winrevair (sotatercept-csrk) significantly improved a key measure of heartlung function in a mid-stage...

8 Observations on NerPharMa FDA-483

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FDA releases the form FDA-483 issued following an inspection at the Milan, Italy-based NerPharMa drug manufacturing facility.

Revisions Sought to Draft Safety Labeling Changes Guidance

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Three stakeholders ask FDA to consider making specific revisions to its draft guidance on new safety labeling change provisions in...

Bill to Strengthen Biopharmaceutical Manufacturing

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Sens. Chris Coons and Ted Budd introduce legislation to promote improvements in U.S. biopharmaceutical manufacturing through a new...

FDA Launches Pilot to Speed Up Meeting Minutes

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FDA launches a new meeting minutes pilot program aimed at reducing delays and confusion that often follow formal meetings between ...

Siemens Healthineers Warning on MRI Machines

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Siemens Healthineers issues an urgent safety correction (Class 1 recall) for dozens of its 3 Tesla MRI models after identifying a ...

Firm to Pay $38.5 Million Over Failed Knee Implants

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Aesculap Implant Systems agrees to pay $38.5 million to resolve federal allegations under the False Claims Act that it knowingly s...

Individuals Accused of Extorting Indias Hetero Drugs

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A business TV station in India says two persons have been arrested for impersonating FDA officials and attempting to extort Hetero...

Epcoritamab Combo for Relapsed Follicular Lymphoma OKd

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FDA approves Genmabs Epkinly (epcoritamab-bysp) for combination with lenalidomide and rituximab in adults with relapsed or refract...

Verdure Sciences Did Not Submit Trial IND: FDA

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FDA warns Noblesville, IN-based Verdure Sciences about failing to submit an IND for a clinical study of its investigational drug M...