FDA Archives - Page 62 of 220

4 minute read

Vistagen Announces Results Of U.S. Phase 1 Study Of Itruvone, Enabling U.S. Phase 2B Development For Treatment Of Major Depressive Disorder

June 21, 8:31 AM

The U.S. Phase 1 data build on successful Phase 1 and Phase 2A clinical studies of itruvone previously conducted outside the U.S. Itruvone was well-tolerated and demonstrated a favorable safety and tolerability profile

VTGN

2 minute read

DiaMedica Therapeutics Announces That The FDA Has Removed The Clinical Hold On DM199 Phase 2/3 Trial For Ischemic Stroke

By Happy Mohamed

June 21, 8:16 AM

DiaMedica Therapeutics Inc. (NASDAQ:DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, announced today that the U.S. Food and Drug

DMAC

2 minute read

PharmaTher’s Novel Ketamine Heads For The US Market With New Collaboration Agreement

By Lara Goldstein

June 20, 10:38 PM

Psychedelics biotech PharmaTher Holdings (OTCQB: PHRRF) has entered into a collaborative partnership with pharma marketing company Vitruvias Therapeutics for the commercialization of its proprietary racemic ketamine products, KETARX, in the U.S. market.

PHRRF

1 minute read

After FDA Rejection, Surmodics’ SurVeil Drug-Coated Balloon Scores FDA Approval

By Vandana Singh

June 20, 9:54 AM

The FDA has approved Surmodics Inc's (NASDAQ: SRDX) SurVeil drug-coated balloon (DCB), a next-generation device

ABT

1 minute read

Zynex Receives FDA Clearance Of CM-1600 Monitor For Improved Blood And Fluid Management

By Happy Mohamed

June 20, 9:15 AM

Zynex, Inc. (NASDAQ:ZYXI), an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, rehabilitation, and patient monitoring, today

ZYXI

1 minute read

Arcellx’s Lead Product Candidate Hit By FDA Clinical Hold For Multiple Myeloma, Stock Falls

By Vandana Singh

June 20, 8:19 AM

The FDA has put a clinical hold on Arcellx Inc's (NASDAQ: ACLX) iMMagine-1 Phase 2 clinical program for CART-ddBCMA investigational new drug for

ACLX

3 minute read

Arcellx Announces Clinical Hold For Its iMMagine-1 Phase 2 Clinical Program; FDA Has Provided Clearance To The Co To Continue Dosing Patients Who Have Already Undergone Lymphodepletion

By Happy Mohamed

June 19, 7:51 PM

Arcellx, Inc. (NASDAQ:ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, announced today that it has

ACLX

2 minute read

AVITA Medical Announces FDA Approval Of RECELL For Skin Repigmentation In Vitiligo Patients

By Benzinga Newsdesk

June 16, 2:47 PM

AVITA Medical, Inc. (NASDAQ:RCEL, ASX: AVH)))), a regenerative medicine company leading the development and commercialization of first-in-class devices and autologous cellular therapies for skin restoration, today announced that the U.S.

RCEL

2 minute read

Eli Lilly And Company Announced Results Of The CHALLENGE-MIG Clinical Trial Of Emgality In Episodic Migraine Prevention; Did Not Achieve Statistical Superiority Versus Active Comparator On The Primary Endpoint

By Benzinga Newsdesk

June 16, 12:04 PM

Emgality demonstrated robust efficacy for patients consistent with previous studies, although it did not achieve statistical superiority versus active comparator on the primary endpointEmgality performed numerically

LLY