FDA Archives - Page 102 of 220

1 minute read

FDA Approves Regeneron-Sanofi’s Sarilumab As First Biologic For Stiffness, Pain In Muscles

March 1, 11:28 AM

The FDA approved Regeneron Pharmaceuticals Inc’s (NASDAQ:REGN) and Sanofi SA’s (NASDAQ:SNY) Kevzara (sarilumab) for polymyalgia rheumatica (PMR), an inflammatory rheumatic disease, The approval…

REGN

1 minute read

Atyr Pharma’s Efzofitimod Has Received FDA For Systemic Sclerosis (SSc) And Fast Track Designation For SSc-Associated Interstitial Lung Disease (SSc-ILD); Proof-of-concept Study In SSc-ILD Expected To Begin In 2023

By Benzinga Newsdesk

March 1, 9:22 AM

The Phase 2 study is expected to be a randomized, double-blind, placebo-controlled, proof-of-concept study to evaluate the efficacy, safety and tolerability of efzofitimod in patients with SSc-ILD. This is expected to be

LIFE

2 minute read

Novavax Ushers New CEO On Uncertainty Concerns, Says It Needs To Work On Competitive COVID-19 Product

By Vandana Singh

March 1, 9:19 AM

COVID-19 vaccine maker Novavax Inc (NASDAQ: NVAX) shares plunged after it

NVAX

1 minute read

Why Reata Pharma Shares Are Skyrocketing Today

By Vandana Singh

March 1, 6:17 AM

The FDA approved Reata Pharmaceuticals Inc’s (NASDAQ:RETA) Skyclarys (omaveloxolone) for Friedreich’s ataxia in adults and adolescents aged 16 and older. With…

RETA

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

By Happy Mohamed

March 1, 1:25 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

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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

February 28, 12:34 PM

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

February 28, 9:57 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

February 28, 9:09 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

February 28, 1:56 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

February 27, 5:44 PM

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