The FDA bestows a Breakthrough Therapy designation to Sanofi's (SNY) efanesoctocog alfa for the treatment of people with hemophilia A.
Regeneron Pharmaceuticals Inc. REGN, -0.88% announced Thursday an agreement in which it will pay up to $1.1 billion plus royalties for Sanofi S.A.'s SNY, -0.08% stake in the Regeneron-Sanofi collabora

Biotech Stock Roundup: BMY's Opdivo Updates, Pipeline Updates From REGN, BIIB

06:39pm, Wednesday, 01'st Jun 2022 Zacks Investment Research
Regulatory and pipeline updates from Regeneron (REGN) and Biogen (BIIB) are a few key highlights from the biotech sector during the past week.

FDA Delays Decision on TGTX's BLA for Multiple Sclerosis Drug

06:22pm, Wednesday, 01'st Jun 2022 Zacks Investment Research
The FDA extends PDUFA date by three months on TG Therapeutics' (TGTX) regulatory submission for ublituximab for relapsing multiple sclerosis. Shares fell 14.5% following the announcement.
The FDA extends PDUFA date by three months on TG Therapeutics' (TGTX) regulatory submission for ublituximab for relapsing multiple sclerosis. Shares fell 14.5% following the announcement.

Amgen (AMGN) Olpasiran Lowers Lipoprotein Levels in Phase II

12:47pm, Wednesday, 01'st Jun 2022 Zacks Investment Research
Amgen's (AMGN) olpasiran, a small interfering RNA molecule, is designed in such a way that it lowers the body's production of apolipoprotein(a), a key component of Lp(a) which increases the risk of ca
Sanofi SNY, -3.45% SAN, +1.17% said Wednesday that the Food and Drug Administration granted a Breakthrough Therapy designation to the hemophilia A treatment it's developing with Swedish Orphan Biovitr

Sanofi's (SNY) Dupixent Prurigo Nodularis NDA Gets Priority Tag

02:16pm, Tuesday, 31'st May 2022 Zacks Investment Research
The FDA grants priority review to Sanofi's (SNY) sBLA for Dupixent to include adults with prurigo nodularis, a chronic inflammatory skin disease.
The U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for review submitted by Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi (NASDAQ: SNY) f
The setback could raise fears about the future of the French company's consumer division, which is also seeing delays in an OTC version of Tamiflu.
Market downturns don't affect stocks equally.

Sanofi: Reliance On One Drug Strategy May Bite

02:29am, Friday, 27'th May 2022
Sanofi's strong reliance on a single product Dupixent poses risks as competition in atopic dermatitis segment increases. It struggled to show any superiority in COVID-19 vaccine development and is sti

Why Regeneron Investors Shouldn't Fear Its Patent Cliff

11:42am, Thursday, 26'th May 2022 The Motley Fool
New treatments will step in to replace blockbuster eye medication EYLEA.

Biotech Stock Roundup: ETTX Up on Acquisition Deal, REGN Offers Updates

02:06pm, Wednesday, 25'th May 2022 Zacks Investment Research
Regulatory updates and acquisition news from Entasis (ETTX) and Regeneron (REGN) are a few key highlights from the biotech sector during the past week.

Sanofi, Regeneron's Dupixent Gets FDA Nod for 4th Indication (Revised)

05:09am, Wednesday, 25'th May 2022 Zacks Investment Research
The FDA approves Sanofi's (SNY) Dupixent for treating adults and children aged 12 and older with eosinophilic esophagitis, a chronic, progressive inflammatory disease.
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