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Gilead Sciences sBLA for Trodelvy

[ Price : $8.95]

Gilead Sciences files a sBLA for Trodelvy (sacituzumab govitecan-hziy), seeking expanded approval in patients with HR+/HER2- metas...

Medtronic Recalls Cobalt & Crome Defibrillators

[ Price : $8.95]

Medtronic recalls its Cobalt and Crome implantable cardioverter defibrillators because the devices have the potential for reduced ...

Dyad Medical AI Echocardiogram App Cleared

[ Price : $8.95]

FDA clears a Dyad Medical 510(k) for its echocardiogram application called Echo:Prio.

2 Children Die After Taking Novartis Gene Therapy

[ Price : $8.95]

Weeks after being administered a Novartis gene therapy, two children die of acute liver failure, according to the company.

Info Collection on Device Sterilization Agreements

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension entitled Agreement for Shipment of Devices for Steri...

9 ICH Vet Med Guidances Published

[ Price : $8.95]

FDA posts nine guidances released by the International Cooperation on Harmonization of Technical Requirements for Registration of ...

Roche Xofluza OK for Acute Uncomplicated Flu

[ Price : $8.95]

FDA approves a Roche a supplemental NDA for Xofluza (baloxavir marboxil) for treating acute uncomplicated influenza in certain chi...

4 Senators Urge Study on Pulse Oximeters

[ Price : $8.95]

Citing lingering questions about pulse oximeters, four Senate Democrats urge FDA to initiate a post market study of the devices.

Daiichi Sankyo Enhertu Approved for Lung Cancer

[ Price : $8.95]

FDA grants Daiichi Sankyo accelerated approval for Enhertu for treating adult patients with unresectable or metastatic non-small c...

Suit Questions FDA Patent Certification Authority

[ Price : $8.95]

Attorney Sara Koblitz says an Avadel suit against FDA challenges the agency's authority to list some patents in the Orange Book an...