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Live News REGULATION FLASH L impact Sep 30, 2026, 05:05 AM UTC

Roche Says FDA Accepts Roche NDA For Fenebrutinib Under Priority Review

ROCHE HOLDING AG BX:RHO

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Bayer Says Bluerock Therapeutics' Investigational Cell Therapy Lemiretprocel (Opct-001) Granted Orphan Drug FDA, EMA Designations BAYER AG XETR:BAYN L impact | REGULATION | Sep 30, 2026, 06:35 AM UTC Tullow Oil loses $196.5 million tax dispute against Ghana Tullow Oil said an ICC tribunal ruled against it in a $196.5 million tax dispute with Ghana, rejecting claims over Ghana corporate income tax on insurance proceeds (2016-2019) and M impact | REGULATION | Sep 30, 2026, 06:21 AM UTC Mayne Pharma Settles IMVEXXY Patent Litigation With Sun Pharma CANBERA (dpa-AFX) - Mayne Pharma Group Limited (MYX.AX) has reached settlement with Sun Pharmaceutical Industries Ltd. (SUNPHARMA.NS), resolving the Paragraph 1V patent litigation L impact | REGULATION | Sep 30, 2026, 05:16 AM UTC Roche: FDA Accepts Fenebrutinib Application For Priority Review In Relapsing And Primary Progressive Multiple Sclerosis First BTK Inhibitor To Receive FDA Filing Acceptance For Both Forms Of MS - Reduced Relapses By 51% And 58% Versus Teriflunomide In Phase III Relapsing MS Trials - Slowed Disabilit L impact | REGULATION | Sep 30, 2026, 05:03 AM UTC Roche (RHO) Wins FDA Priority Review for Fenebrutinib in RMS and PPMS Roche said the FDA accepted its NDA under priority review for fenebrutinib, a BTK inhibitor for relapsing and primary progressive multiple sclerosis, supported by three Phase III s L impact | REGULATION | Sep 30, 2026, 05:01 AM UTC Roche’s fenebrutinib is the first BTK inhibitor to receive U.S. FDA filing acceptance in both relapsing and primary progressive multiple sclerosis Basel, 30 September 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the United States Food and Drug Administration (FDA) has accepted the company’s New Drug Applicat L impact | REGULATION | Sep 30, 2026, 05:01 AM UTC

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