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Replimune BLA Resubmission for Melanoma Therapy

[ Price : $8.95]

FDA accepts for review a Replimune BLA resubmission for RP1 (vusolimogene oderparepvec) in combination with nivolumab for treating...

Roches Giredestrant Combo Shows Positive Phase 3 Data

[ Price : $8.95]

Roche reports new favorable data from the Phase 3 evERA Breast Cancer study of its investigational oral therapy giredestrant, used...

Cell, Gene Therapy Monitoring Guide Encouraging: Attorneys

[ Price : $8.95]

Attorneys at Hyman, Phelps & McNamara say they are encouraged by an FDA draft guidance outlining a roadmap for postapproval monito...

AdvaMed Proposes MAHA Pathway for Devices

[ Price : $8.95]

The Advanced Medical Technology Association outlines a series of recommendations aimed at strengthening U.S. leadership in medical...

Summits Ivonescimab Outperforms Tislelizumab in Trial

[ Price : $8.95]

Summit Therapeutics reports that its investigational bispecific antibody ivonescimab, when combined with chemotherapy, significant...

FDA Updates Rybelsus Label for CV Risk Reduction

[ Price : $8.95]

FDA approves a new indication for Novo Nordisks Rybelsus (oral semaglutide) tablets to reduce the risk of major adverse cardiovasc...

Kenvue Urges FDA to Reject Acetaminophen Petition

[ Price : $8.95]

Kenvue urges FDA to deny a recent citizen petition requesting updates to the pregnancy warning on acetaminophen products.

FDA Drug Approval Trends Slipping: Financial Analysts

[ Price : $8.95]

A new report by RBC Capital Markets finds a slowdown in FDA drug approvals, a rise in rejected applications, and an increase in de...

Celltrions Yuflyma Expanded Approval for Younger Patients

[ Price : $8.95]

FDA approves expanded indications for Celltrions Yuflyma (adalimumab-aaty) to include treating hidradenitis suppurativa in adolesc...

9 Vouchers Awarded Under New Priority Review Pilot

[ Price : $8.95]

FDA names the first nine voucher recipients under the recently launched Commissioners National Priority Voucher pilot review progr...