The FDA has granted Priority Review to nipocalimab for the treatment of antibody positive patients with generalized myasthenia gravis.

The U.S. Food and Drug Administration has approved Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with ...

Replimune Group ( REPL, Financials) shares surged 17% to $11.85 as of 10:18 a.m. ET Tuesday after the U.S. Food and Drug Administration granted Priority Review for its Biologics License Application ...

The FDA has accepted a BLA for treatment with RP1 in combination with Opdivo for patients with advanced melanoma who have ...

PDUFA action date of July 22, 2025, with priority reviewWOBURN, Mass., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the ...

The drug, shown to be almost as effective as opioids for short-term pain, is the first fundamentally new kind of painkiller ...

A priority review designation means that the goal of the FDA is to act on an application within six months, as opposed to 10 months under standard review, and a priority review designation “will ...

The FDA grants Priority Review to applications for medicines that ... new cases and 8,000 deaths estimated in the U.S. in 2024.i Standard of care therapy includes treatment with immune checkpoint ...

These launches are positioned for multi-blockbuster status, thanks to their promise of fulfilling unmet needs, impacting ...

Shares of Chimerix CMRX have skyrocketed 323.7% in the past three months following the company’s submission of a new drug ...

Inc. stock despite strong Phase 2b data. Click for my updated look at MNMD stock and its market opportunities.

Approval of Enhertu marks the first HER2-directed therapy indicated for adults with unresectable or metastatic HR-positive, ...