FDA Archives - Page 116 of 220

3 minute read

ImmunityBio Announces Presentation At ASCO GI 2023 Of Fully Enrolled Trial In Third-Line And Greater Pancreatic Cancer And Update On FDA Type B Meetings Regarding Paths To Registration

January 19, 10:10 AM

Positive findings in third line and greater metastatic pancreatic cancer patients (N=83) with doubled median overall survival (OS) versus historical OS Median overall survival of 5.8 months and 61% of

IMRX

4 minute read

Vistagen Poised To Begin Phase 1 Trial Of A Fast-Acting Antidepressant Nasal Spray In Q1 2023

By Benzinga Newsdesk

January 19, 9:34 AM

In the race to create faster-acting, safer antidepressants, Vistagen (NASDAQ:VTGN) is starting the year strong as it gets ready to launch a Phase 1 Trial of its novel pherine nasal spray for Major Depressive

CMPS

1 minute read

Surmodics Provides Regulatory Update Related To Its FDA Premarket Approval Application For The SurVeil Drug-Coated Balloon

By Benzinga Newsdesk

January 19, 8:01 AM

Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced it has received a letter from the U.S. Food and Drug Administration

SRDX

1 minute read

NRx Pharmaceuticals Provided Progress Update on Interactions with the FDA regarding Path to NDA Submission for NRX-101; Said It Appears That NRX Pharmaceuticals Has Reached Alignment With The Fda Regarding Its Proposed Registration Manufacturing Plan.

By Charles Gross

January 19, 7:49 AM

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage central nervous system (CNS) biopharmaceutical company, today announced that it had a meeting and a written response from the Food and Drug Administration (FDA) last week regarding its lead compound, NRX-101.

NRXP

1 minute read

Shuttle Pharma Has Received A Notice Of Allowance For Its U.S. Patent App 16/475,999 Titled “Methods & Compositions For Cancer Therapies That Include Delivery Of Halogenated Thymidines & Thymidine Phosphorylase Inhibitors In Combination With Radiation”

By Benzinga Newsdesk

January 18, 12:23 PM

https://patentcenter.uspto.gov/#!/applications/16475999/ifw/docs

SHPH

1 minute read

BriaCell Announces End Of Phase II Meeting With FDA For Bria-IMT Combination In Advanced Metastatic Breast Cancer; FDA Has Agreed On Primary Endpoint

By Bill Haddad

January 18, 9:49 AM

BriaCell has received agreement and positive feedback from its End of Phase II meeting with the FDA for lead clinical candidate, Bria-IMT™ in combination with a checkpoint inhibitor, in advanced metastatic breast

BCTX

4 minute read

RenovoRx Announces Initial Results In Pharmacokinetic Substudy: Data On RenovoGem Supports Potential For RenovoTAMP Therapy Platform To Increase Local Gemcitabine Delivery And Decrease Side Effects Of Pancreatic Cancer Treatment

By Benzinga Newsdesk

January 18, 9:40 AM

Researchers presenting four abstracts on different substudies, including the preliminary PK substudy, at the ASCO GI Cancers Symposium in San Francisco on January 19-21, 2023. RenovoRx, Inc. (NASDAQ:RNXT), a

RNXT

3 minute read

Reported Late Tuesday, Everest Medicines Announces Top-Line Data From Phase I Study Of EVER206 On Healthy Subjects In China; Study Findings Suggest That EVER206 Is Well-Tolerated With No New Safety Signals. NOTE: Spero Granted Pfizer The Rights To Deve…

By Benzinga Newsdesk

January 18, 1:26 AM

Study findings suggest that EVER206 is well-tolerated with no new safety signals, supporting next-phase clinical development in China

FXI

1 minute read

FDA
News

Reported Earlier, Cardiol Therapeutics Says First Patient Enrolled In Phase 2 Study Of CardiolRx For Pericarditis

By Benzinga Newsdesk

January 17, 4:05 PM

Cardiol Therapeutics CEO David Elsley shared news the company has hit a major milestone in that the first patient has been enrolled in a Phase II open-label pilot study of CardiolRx in patients with recurrent pericarditis.

CRDL

1 minute read

FDA Approves Abbott’s Next-Gen Navitor TAVI System For Aortic Stenosis

By Vandana Singh

January 17, 2:11 PM

The FDA has approved Abbott Laboratories (NYSE:ABT) latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor, to treat people with severe…

ABT