With a second phase 3 win for Tyvaso in idiopathic pulmonary fibrosis (IPF), United Therapeutics is padding the case for an ...
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SRRK stock jumps on resubmission of FDA filing for SMA drug
Shares of Scholar Rock SRRK rose 14% on Tuesday after the company announced the resubmission of a regulatory filing to the ...
CEO Richard Adcock used a presentation at the Citizens Life Sciences Conference to outline the company’s commercial progress ...
MoonLake Immunotherapeutics MLTX shares are volatile on Monday as the company is reporting long-term results from its VELA-1 ...
Mitapivat has been approved in the US under the Pyrukynd trade name since 2022 as a treatment for haemolytic anaemia in ...
The company is seeking clearance in additional gynecological indications to support outpatient use of its surgical robot.
National shareholder rights law firm Hagens Berman is updating its investigation into uniQure N.V. (NASDAQ: QURE) a series of extraordinary rebukes by Food and Drug Administration (FDA) officials.
MIRA trial data demonstrated a 43% response with 120mg SLK, and a 29 ppt delta vs placebo (p < 0.001) at week 12. VELA-1 met all primary and key secondary endpoints with statistical significance ...
Teva’s biosimilar, PONLIMSI™, is now FDA-approved across all indications of the reference product, Prolia® (denosumab), to ...
WASHINGTON — The U.S. Food and Drug Administration is refusing to consider Moderna’s application for a new flu vaccine made with Nobel Prize-winning mRNA technology, the company announced Tuesday. The ...
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