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

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 ...

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 ...

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

Q4 2024 Earnings Call Transcript March 11, 2025 Operator: Greetings, and welcome to the Achieve Life Sciences Fourth Quarter ...

Q4 2024 Earnings Call Transcript March 13, 2025 aTyr Pharma, Inc. beats earnings expectations. Reported EPS is $-0.18, expectations were $-0.23. Operator: Good afternoon, ladies and gentlemen, and ...

In an alopecia areata trial, a novel bifunctional therapy that blocks signaling of the interleukin-7 and TSLP pathways ...

Phase 3 AURORA trial of Descartes-08 in myasthenia gravis on track to commence in 1H25; Deep and durable responses maintained over 12 months in Descartes-08-treated participants in Phase 2b trial ...

The Phase 1 trial is an open label, dose ranging clinical study designed to evaluate Vaxart’s second-generation oral norovirus vaccine constructs head-to-head against its first-generation constructs.

Reached key milestones in the ORCA-OL long-term exposure trial, including completion of enrollment and meeting the requirement of 300 participants receiving six months of cumulative cytisinicline ...