FDA - Spark Newswire

4 minute read

Reported Late Tuesday Feb. 28, Regeneron Pharmaceuticals And Sanofi Announce Kevzara Approved By FDA As First And Only Biologic Indicated For Patients With Polymyalgia Rheumatica

Today, 11:00 AM

Three times more patients treated with Kevzara achieved sustained remission compared to placebo in Phase 3 trial Kevzara now approved to treat two chronic inflammatory disorders TARRYTOWN, N.Y. and CAMBRIDGE,

REGN

1 minute read

BioAffinity Technologies, Subsidiary Oncoselect Therapeutics, Has Been Granted U.S. Patent Number 11,590,233 Titled “Porphyrin Compounds And Compositions Useful For Treating Cancer”

By Happy Mohamed

Today, 11:00 AM

https://ppubs.uspto.gov/pubwebapp/external.html?q=(11590233).pn

BIAF

2 minute read

Hyperfine, Inc. Receives FDA Clearance For Updated Software To Further Improve Diffusion-Weighted Imaging

By Happy Mohamed

Today, 11:00 AM

Hyperfine, Inc. (NASDAQ:HYPR), the groundbreaking medical device company that created the Swoop® system, the world's first FDA-cleared portable MRI system, today announced the U.S. Food and Drug Administration

HYPR

2 minute read

Kiromic BioPharma Reports Favorable Deltacel Preclinical Pharmacology Results

By Happy Mohamed

Today, 11:00 AM

Favorable Safety Results are Last Component Needed to Complete the Nonclinical Module of the Company's IND Application IND Submission and Activation of Clinical Trial Process on Track for the First

KRBP

2 minute read

Reported Late Monday Feb. 27, Eisai Co. And Biogen Inc. Announce Biologics License Application For Lecanemab Designated For Priority Review By China National Medical Products Administration

By Happy Mohamed

Today, 11:00 AM

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (NASDAQ:BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, ", , Biogen", , ))))

BIIB

2 minute read

Verrica Pharmaceuticals Announces FDA Acceptance Of Filing Of Resubmitted NDA For VP-102 For The Treatment Of Molluscum Contagiosum; Assigns PDUFA goal date of July 23, 2023

By Happy Mohamed

Today, 11:00 AM

Assigns PDUFA goal date of July 23, 2023 VP-102 (cantharidin 0.7% Topical Solution) could potentially be the first FDA-approved treatment for molluscum contagiosum, a highly contagious

VRCA

2 minute read

Aptinyx Reports Results From Phase 2 Study Of NYX-458 In Cognitive Impairment Associated With Parkinson’s Disease And Dementia With Lewy Bodies And Provides Pipeline And Corporate Update; Will Undertake Cost-Cutting Measures And Explore Alternatives

By Happy Mohamed

Today, 11:00 AM

NYX-458 did not demonstrate sufficient efficacy in the Phase 2 study to support further development by Aptinyx The company will undertake cost-cutting measures and explore strategic alternatives The company

APTX

1 minute read