The FDA’s Oncologic Drugs Advisory Committee recently voted to narrow the label for checkpoint inhibitors Keytruda and Opdivo ...

Patients enroll in phase 2 oncology trials seeking access to promising new treatments, but the risk-benefit assessments and ...

Head of the Food and Drug Monitoring Agency (BPOM) Taruna Ikrar expressed confidence that the nutri-grade policy, or labeling ...

FDA took issue with the promotional communication presented in an exhibit booth panel (“panel”) [2] for Hemady ®, a drug indicated in combination with other anti-myeloma products for the treatment of ...

Results from the open-label extension of its Phase 2 SPRING ... and alignment with FDA on the design of a single Phase 3 registration study for its lead product candidate nebokitug (CM-101 ...

In this edition of “Rising High,” The Fly conducted an exclusive interview with Jared Stanley, Chief Executive Officer, and Joel Stanley, ...

We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority ...

Fast track was first introduced by FDA to expedite development and review of drugs to treat serious conditions lacking any FDA-approved drug,” commented Gary S. Jacob, Ph.D., Chief Executive Officer ...

Jazz Pharmaceuticals acquires Chimerix (CMRX) for $935M, adding ONC201, a promising brain cancer drug. Find out why I believe ...

Bioheng Therapeutics’ IND application for CTD402 gets US FDA clearance for CD7 UCAR T cell therapy in T-cell acute lymphoblastic leukemia: Boston Friday, March 7, 2025, 16:00 Hr ...

In the trials, omalizumab and multi-allergen oral immunotherapy showed alike efficacy in protecting against food allergies, ...