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biotechs: Archive

Zacks Equity Research

GSK's Utebzi Wins FDA Nod for Complicated Urinary Tract Infections

GSK wins FDA approval for Utebzi, the first oral carbapenem for complicated UTIs, further expanding its anti-infectives portfolio.

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DNTH Shares Surge 89% Over the Past Six Months: What's Driving It?

Dianthus Therapeutics stock climbs 89% in six months as claseprubart advances across key autoimmune studies. Strong cash position supports development into 2030.

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MRNA Stock Jumps as FDA Briefing Docs Ease Flu Shot Approval Concerns

Moderna jumps after FDA briefing documents on mFlusiva appear more constructive than expected ahead of a key advisory panel review.

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Cytokinetics Gains 18.4% Year to Date: How to Play the Stock?

CYTK has gained 18.4% YTD as Myqorzo's FDA approval, early launch momentum, and expanding market opportunities fuel investor interest.

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OTLK Stock Up 35% as FDA Accepts Resubmitted Eye Drug BLA for Review

Outlook Therapeutics stock surges 35% after the FDA accepts the resubmitted Lytenava BLA for wet AMD for review, setting a July 29, 2026, decision date.

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Is it a Good Idea to Invest in Immunocore Stock Right Now?

IMCR is seeing strong Kimmtrak sales growth and pursuing label expansion studies that could broaden its reach across melanoma treatments.

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MIRM, INCY Report Positive Rare Disease Data as FDA Begins NDA Review (Revised)

Mirum and Incyte's zilurgisertib cut new bone lesion formation in rare disease FOP, as the FDA begins Priority Review of the NDA with a Sept. 26, 2026, decision date.

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Can BMY's Camzyos Strengthen Its Cardiovascular Portfolio?

Bristol Myers eyes growth from Camzyos as the FDA reviews its use in adolescents with obstructive HCM, expanding the drug's market reach.

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Zacks Equity Research

FDA Accepts Gilead's Filing for Weekly Oral Yeztugo for HIV Prevention

Gilead seeks FDA approval for once-weekly oral Yeztugo for HIV prevention, aiming to expand access with a new long-acting PrEP option.

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FDA Accepts AstraZeneca's Filing for Expanded Use of Ultomiris

AZN's Ultomiris wins FDA priority review for IgAN, backed by late-stage data showing a 43.4% proteinuria reduction versus placebo.

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