Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna has ...
Moderna said the move is inconsistent with previous feedback from the FDA on the experimental influenza shot, called ...
Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna has requested a Type A meeting to understand the path forwardmRNA-1010 has been ...
The Food and Drug Administration rejected Moderna’s application for its mRNA-based flu vaccine, the drugmaker said Tuesday ...
Kailera will launch a global Phase 2 study of ribupatide this year, while Hengrui will push the asset into Phase 3 in China.
Investing.com-- Moderna Inc (NASDAQ: MRNA ) shares fell sharply in aftermarket trade on Tuesday after it said the U.S. Food and Drug Administration had refused to review its influenza vaccine ...
Kessler Topaz Meltzer & Check, LLP informs investors that the firm has filed a securities fraud class action lawsuit against uniQure N.V. (NASDAQ: QURE) (“uniQure” or the “Company”) on behalf of ...
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Moderna takes it on the chin after FDA rejects its messenger-RNA-based flu shot
The FDA rejected Moderna's experimental flu vaccine Tuesday in a move that proved to be a blow to recently hot Moderna stock.
The FDA recommended that REGENXBIO run a new study, treat more patients and include a placebo arm to support a resubmission ...
Roche’s phase III FENtrepid study of fenebrutinib meets its primary endpoint of non-inferiority compared to Ocrevus in reducing disability progression in patients with PPMS ...
The firm will test the FSHR-targeting lira-cel at up to 100-tmes higher doses after seeing better than expected outcomes at ...
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