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PureTech Orphan Status for Pancreatic Cancer Drug

[ Price : $8.95]

FDA grants PureTech Health an orphan drug designation for LYT-200 and its use in treating pancreatic cancer.

Topline Data Confirm Semorinemab Effect on Alzheimers

[ Price : $8.95]

Data presented by Genentech show AC Immunes semorinemab reduced cognitive decline compared to placebo in a Phase 2 Alzheimers dise...

Dont Approve Eagle Vasostrict ANDA Yet: Par

[ Price : $8.95]

Par asks FDA not to approve an Eagle ANDA referencing Vasostrict until specified changes are made regarding the pH specification.

FDA OKs Resumption of Inovio Covid Vaccine Trial

[ Price : $8.95]

FDA authorizes Inovio to proceed with the Phase 3 INNOVATE segment of its investigative DNA Covid vaccine clinical trial.

FDA Clinical Hold on Pfizer Hemophilia A Trial

[ Price : $8.95]

FDA places a clinical hold on a Pfizer Phase 3 trial of a gene therapy candidate to treat hemophilia A.

Ellume Covid Test Recall is Class 1: FDA

[ Price : $8.95]

FDA says the Ellume recall of certain lots of its Covid-19 home test due to an unacceptable level of false-positive results is Cla...

HeartVista MRI Software Cleared for Siemens Scanner

[ Price : $8.95]

FDA clears a HeartVista 510(k) to provide its artificial intelligence-assisted One Click MRI acquisition software on Siemens Healt...

Aligned Medical Solutions Recalls Convenience Kits

[ Price : $8.95]

Aligned Medical Solutions recalls its custom convenience kits due to the potential for the plunger on the Cardinal Health Monoject...

Meridian Bio EUA for Covid Assay

[ Price : $8.95]

FDA grants Meridian Bioscience an emergency use authorization for its Revogene SARS-CoV-2 assay, a molecular diagnostic test for t...

Kalo Paying $12.7 Million to End False Claims Case

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The Justice Department says kalo is paying $12.7 million to resolve a whistleblowers allegations that it induced false claims for ...