FDA Archives - Page 168 of 220

3 minute read

September 28, 5:45 PM

Dupixent significantly reduced itch and skin lesions compared to placebo in direct-to-Phase 3 program consisting of two pivotal trials About 75,000 adults in the U.S. living with prurigo nodularis are most in need of

REGN

2 minute read

Atara Biotherapeutics To Receive Additional Near-Term Milestone Payment Under Updated Tabelecleucel Commercialization Agreement With Pierre Fabre; Atara To Receive Additional $30M Upon European Commission Approval And Filing Of Tab-Cel

By Benzinga Newsdesk

September 28, 4:03 PM

Atara to Receive Additional USD 30 Million Upon European Commission (EC) Approval and Filing of Tab-cel® Marketing Authorization Transfer to Pierre Fabre Responses Submitted to European Medicines

ATRA

3 minute read

Cyclo Therapeutics On Track To Commence Enrollment & Dosing Of Phase 2 Study Of Trappsol Cyclo For Treatment Of Alzheimer’s Disease Before Year End

By Benzinga Newsdesk

September 28, 2:08 PM

– Company on track to commence enrollment and dosing of Phase 2 study of Trappsol® Cyclo™ for the treatment of Alzheimer's disease before year end – Ongoing advancement of global pivotal study (TransportNPC™) evaluating Trappsol® Cyclo™ for Niemann-Pick Disease Type C1 (NPC1)

CYTH

2 minute read

Immunovant Announces IMVT-1402, A Next Generation Anti-FcRn; Plan To Submit IND And Initiate Phase 1 Study In Early 2023 With Initial Data Expected In Mid-2023.

By Benzinga Newsdesk

September 28, 10:47 AM

In animal studies, deep IgG lowering similar to batoclimab with no or minimal impact on albumin and low-density lipoprotein (LDL) was observed. Plan to submit IND and initiate Phase 1 study in early 2023

IMVT

1 minute read

FDA
News

Zhongchao Establishes Chongqing Xinjiang Pharmaceutical To Improve Patient Access To Medications

By Benzinga Newsdesk

September 28, 9:25 AM

Zhongchao Inc. (NASDAQ:ZCMD) ("Zhongchao" or the "Company"), a platform-based internet technology company offering services to patients with oncology and other major diseases, today announced

ZCMD

2 minute read

Sight Sciences To Feature Interactive Panel Discussions Of Real-World Use Of The OMNI Surgical System As A Standalone Glaucoma Treatment At American Academy Of Ophthalmology Annual Meeting October 1-2

By Benzinga Newsdesk

September 28, 8:39 AM

MENLO PARK, Calif., Sept. 28, 2022 (GLOBE NEWSWIRE) -- Sight Sciences, Inc. (NASDAQ:SGHT), today announced that 12 ophthalmic physicians will present their first-hand experience using the OMNI Surgical System as a

SGHT

2 minute read

RenovoRx Announces Presentation At Symposium On Clinical Interventional Oncology Highlighting Its Innovative Therapy Platform For Targeted Treatment Of Pancreatic Cancer

By Benzinga Newsdesk

September 28, 8:37 AM

RenovoRx, Inc. (NASDAQ:RNXT), a biopharmaceutical company focused on the localized treatment of difficult-to-treat solid tumors through its proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMPTM) therapy

RNXT

1 minute read

CinCor Pharma Announces Late-Breaking Presentation Of Phase 2 BrigHtn Data For Baxdrostat In Treatment-Resistant Hypertension At The Upcoming 2022 American Heart Association Scientific Sessions : November 7

By Benzinga Newsdesk

September 28, 8:27 AM

WALTHAM, Mass., Sept. 28, 2022 (GLOBE NEWSWIRE) -- CinCor Pharma, Inc. (NASDAQ:CINC) today announced that the company will present Phase 2 data from its BrigHtn trial evaluating baxdrostat in patients with

CINC

1 minute read

Thermo Fisher’s Oncomine Dx Test Is First FDA Approved NGS-Based Companion Diagnostic To Detect Thyroid Cancers

By Vandana Singh

September 28, 8:11 AM

The FDA approved Thermo Fisher Scientific Inc’s (NYSE:TMO) Oncomine Dx Target Test as a companion diagnostic (CDx) to select patients with RET-fusion…

LLY

1 minute read

Rallybio Announces Preliminary Results For RLYB212, An Anti-HPA-1a Monoclonal Antibody For The Prevention Of Fetal And Neonatal Alloimmune Thrombocytopenia

By Benzinga Newsdesk

September 28, 8:08 AM

Rallybio Corporation (NASDAQ:RLYB) today announced positive preliminary results from its ongoing Phase 1b proof-of-concept study of RLYB212, an anti-HPA-1a monoclonal antibody for the prevention of fetal and neonatal

RLYB