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Category: Impacting News

TG Therapeutics Announced Positive CHMP Opinion of BRIUMVI for Relapsing Forms of MS in Adults

TG Therapeutics Positive CHMP of BRIUMVI TG Therapeutics, Inc. ( TGTX ) , informed that the Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has recommended the approval of BRIUMVI™...

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April 3, 2023

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Exelixis CABOMETYX: Now Approved in Europe for First-Line Treatment of Renal Cell Carcinoma

Exelixis Boxed in on Good News Exelixis ( EXEL ) is one of the firms boxed in by rule of thumb traders and short-sellers who put enormous pressure on biotech firms regardless of their good news. We sincerely believe that...

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April 1, 2021

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Intellia Therapeutics Announces More Good News

Intellia Therapeutics NTLA-2001 for ATTR Granted Orphan Drug Designation by the EC Intellia Therapeutics ( NTLA ) announced that the European Commission (EC) has granted its product NTLA-2001 orphan drug designation. The investigational product is being developed as a treatment for transthyretin...

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April 5, 2021

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Incyte Announces the FDA Approved its Opzelura Cream for the Treatment of Vitiligo

Incyte Announces FDA Approval of Opzelura Cream for Vitiligo Incyte ( INCY ) announced today, July 19, 2022, that the United States Food and Drug Administration ( FDA ) has approved Opzelura™ (ruxolitinib) cream 1.5% for the topical treatment of...

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July 20, 2022

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Sanofi to Reach Full Commercial Control of the Antibody Beyfortus (nirsevimab) against RSV in the U.S.

Sanofi Commercial Control of Beyfortus Against RSV In the morning, we promised to tell our readers how AstraZeneca's ( AZN ) , Sobi, and Sanofi ( SNY ) simplified their contractual arrangements that enabled Sanofi to reach a full commercial...

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April 12, 2023

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Seagen and Astellas Pharma Announced Positive Topline Results For PADCEV® with KEYTRUDA® as First-Line Treatment for Advanced Urothelial Cancer

Seagen, Astellas Pharma & Merck Collaboration Seagen ( SGEN ) and Astellas Pharma ( ALPMY ) have entered a clinical collaboration agreement with Merck to evaluate the combination of Seagen’s and Astellas’ product PADCEV® (enfortumab vedotin-ejfv) with Merck’s ( MRK...

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July 26, 2022

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Bristol-Myers Squibb Combination Improving the Treatment of Metastatic Melanoma; AbbVie Improving the Treatment of Crohn's Disease

Offsetting the Biotech Firms' Good News There is no doubt that good news is filling the media about outperformances of both development-stage small biotech firms and revenues-generating firms. This good news has been offset by inflation, hiked interest rates, that...

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July 29, 2022

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Regenxbio to File a BLA Using the Accelerated Approval Pathway for RGX-121 for the Hunter Syndrome

Regenxbio in the NEWS  Regenxbio ( RGNX ) announced, on August 3, 2022, its intention to file a Biologics License Application ( BLA ) in 2024 using the FDA's accelerated approval pathway for RGX-121 for the treatment of Mucopolysaccharidosis Type...

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August 3, 2022

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Innoviva: The FDA Advisory Committee Unanimously Recommended Approval of Sulbactam-Durlobactam

News from Innoviva That We Consider Positively Impacting and Extremely Important Innoviva, Inc. ( INVA ) (Innoviva) , announced that the FDA Antmicrobial Drugs Advisory Committee ( AMDAC ) has unanimously voted 12-0 in favor of approval of sulbactam-durlobactam based...

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April 19, 2023

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Gilead Sciences: A Promising Acquisition. See Also: Genmab and BioNTech: A Promising Expansion

Gilead Sciences to Acquire MiroBio At $405 Million Gilead Sciences ( GILD ) and MiroBio - a privately held U.K based biotechnology company focused on restoring immune balance with agonists targeting immune inhibitory receptors, announced that they entered into a...

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August 5, 2022

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