Bayer Secures FDA Nod for Sevabertinib's First-Line Use in NSCLC
BAYRY's sevabertinib wins first-line NSCLC approval. The company advances BAY 3670549 into a phase II AFib study.
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Roche Gets FDA Priority Tag for Enspryng in Rare Autoimmune Disorder
RHHBY's sBLA for Enspryng wins FDA priority tag for myelin oligodendrocyte glycoprotein antibody-associated disease. A decision is due on Jan. 10, 2027.
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Can Papzimeos Drive Precigen's Growth Through the Rest of 2026?
Papzimeos is fueling Precigen's growth, with sales more than doubling sequentially in Q2 and demand continuing to rise in 2026.
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Spyre's Anti-IL-23 Antibody Meets Goal in Ulcerative Colitis Study
Verastem Stock Skyrockets 121% in 3 Months: Here Is Why
VSTM shares surge 121% as Avmapki Fakzynja Co-Pack gains commercial traction and VS-7375 advances across key cancer studies.
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CAPR Stock Skyrockets 144% in a Month: What Is Driving the Rally?
Capricor shares jump in a month as positive phase III data and renewed FDA engagement revive hopes for deramiocel approval in DMD.
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ABBV's Etentamig Meets Goals in Phase III Multiple Myeloma Study
AbbVie's etentamig meets key phase III goals in multiple myeloma, improving response rates and progression-free survival versus standard therapies.
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Krystal Stock Gains 13.4% in a Month: What Is Driving the Rally?
KRYS' Vyjuvek growth and expanding genetic medicine pipeline boost investor confidence as the company advances toward multi-product growth.
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FDA Accepts UTHR's sNDA for Tyvaso in Idiopathic Pulmonary Fibrosis
FDA accepts United Therapeutics' Tyvaso sNDA for an IPF label expansion, backed by TETON data showing improved lung function and reduced clinical worsening.
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RARE Stock Down 46% as Phase III Angelman Syndrome Study Misses Goals
Ultragenyx plunges 46% after its phase III Angelman syndrome study fails to achieve key efficacy goals, putting apazunersen's future in question.