FDA Accepts Application of Tab-Cel, First-in-Class Therapy for EBV+ PTLD
The FDA has accepted and granted priority review to tab-cel, a treatment for Epstein Barr virus-positive posttransplant lymphoproliferative disease.

Behind Hengrui's surprise FDA rejection: Scathing Form 483 lists litany of shortfalls at PD-1 drug plant
A lengthy Form 483 from the FDA listed a range of concerns that led to the agency’s surprise rejection of Jiangsu Hengrui Pharma and Elevar Therapeutics’ PD-1 inhibitor camrelizumab in May.

FDA Grants Fast Track Designation to Abdera Therapeutics’ Treatment for Extensive-Stage Small Cell Lung Cancer
The novel therapy, ABD-147, uses advanced antibody engineering to deliver Actinium-225 to solid tumors expressing DLL3, a protein found on neuroendocrine tumors.

Lawsuit alleges Iowa telepharmacy sold fake Ozempic to Michigan company
An Iowa telepharmacy company faces allegations in a civil lawsuit that it sold counterfeit Ozempic, the high-demand weight-loss drug, to a Michigan company.

FDA data request slows progress of new fentanyl stopper
Swedish drugmaker Orexo (STO:ORX) has been struck by an unexpected delay in its bid to register a high-dose naloxone rescue medication in the USA.

NYC comptroller pressures pharmacies to dispense abortion pill, threatening divestment
New York City Comptroller Brad Lander is pressuring several major pharmaceutical retailers to dispense the abortion pill mifepristone or run the risk of divestment from the New York City pension fund.

Vancouver-based biotechnology company CytoDyn settles lawsuit for $12M
It reaches settlement with its former research contractor Amarex Clinical Research.

FDA Grants Orphan Drug Designation to Novel B7-H3-Targeting ADC in SCLC
7MW3711, an innovative antibody-drug conjugate targeting B7-H3, has been granted an orphan drug designation by the FDA for treating small cell lung cancer.

FDA Highlights the Promise of AI in Healthcare
In its guiding principles, the FDA defines “transparency” as, “the degree to which appropriate information about [machine learning-enabled medical devices] . . . is clearly communicated to relevant audiences.” It goes on to list four key elements of effective transparency.

Globus Medical gets FDA approval for two knee replacement products
Globus Medical (NYSE:GMED) said it has received FDA clearances for its ExcelsiusFlex with Total Knee Arthroplasty robotic navigation platform and ACTIFY 3D Total Knee implant system.




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