FDA Archives - Page 73 of 220

3 minute read

Veru Reaches Agreement With FDA On Confirmatory Phase 3 Clinical Trial For Sabizabulin Treatment Of Hospitalized COVID-19 Adult Patients At High Risk For ARDS

May 4, 8:31 AM

Reached agreement with FDA on confirmatory Phase 3 clinical trial design in 408 subjects with primary endpoint of all-cause mortality at Day 60 Study to expand treatment population to include all WHO-4, WHO-5,

VERU

2 minute read

Humacyte’s Human Acellular Vessel Receives FDA’s Regenerative Medicine Advanced Therapy Designation For Urgent Arterial Repair Following Vascular Trauma

By Happy Mohamed

May 4, 8:19 AM

HAV granted second RMAT designation by the FDA RMAT will support Humacyte's lead indication in Vascular Trauma DURHAM, N.C., May 04, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a clinical-stage

HUMA

2 minute read

Harrow To Launch FDA-Approved IHEEZO At The 2023 American Society Of Cataract And Refractive Surgery Annual Meeting

By Happy Mohamed

May 4, 8:12 AM

Harrow (NASDAQ:HROW), a leading U.S. eyecare pharmaceutical company, today announced the launch of FDA-approved IHEEZO™ at the 2023 American Society of Cataract and Refractive Surgery (ASCRS) annual meeting

HROW

1 minute read

A Shot of Success: GSK’s Arexvy Wins FDA Approval, Pioneering RSV Prevention for Older Adults in Multi-Billion Dollar Market

By Vandana Singh

May 3, 3:38 PM

The FDA has approved GSK Plc's (NYSE: GSK) Arexvy (respiratory syncytial virus vaccine for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals

GSK

1 minute read

Why ImmunoGen Shares Are Shooting Higher Today

By Vandana Singh

May 3, 9:45 AM

ImmunoGen Inc (NASDAQ: IMGN) shares are shooting higher on Wednesday after it announced top-line data from the Phase 3 confirmatory MIRASOL trial (GOG 3045/ENGOT OV-55) evaluating Elahere (mirvetuximab soravtansine-gynx) compared to chemotherapy for folate receptor alpha (FRα)-positive platinum-r

IMGN

3 minute read

Zappy Zapolin Talks Psychedelics And Breakthrough Delivery Methods: The Future Has Arrived And It’s Awesome

By Maureen Meehan

May 3, 9:23 AM

Mike ‘Zappy’ Zapolin, Chief Visionary Officer of Psycheceutical Bioscience, Inc (OTCPK: BWVI), whom we'll call Zappy, shared his vision for the future of psychedelics at the recent Benzinga Psychedelics Capital Conference in Miami.

BWVI

3 minute read

Summit Therapeutics Announces Initial Indications For Clinical Trials For Ivonescimab; Studies Designed In Alignment With Feedback From FDA

By Benzinga Newsdesk

May 3, 8:32 AM

Studies Designed in Alignment with Feedback from FDACompany to Host Q1 Earnings Call on May 11, 2023 at 9:00am ETSummit Therapeutics Inc. (NASDAQ:SMMT) ("Summit," "we," or the "Company") today announced that it has

SMMT

1 minute read

Parkinson’s Patients May Benefit From Ketamine, PharmaTher Applies For FDA Fast Track

By Nicolas Jose Rodriguez

May 3, 7:08 AM

Specialty pharmaceutical company PharmaTher Holdings (OTCQB: PHRRF) has submitted a Fast Track Application to the Food and D

PHRRF

2 minute read

NLS Pharmaceutics Receives Green Light from The U.S. FDA To Proceed With Phase 3 Clinical Program For Quilience For The Treatment Of Narcolepsy

By Benzinga Newsdesk

May 2, 8:54 AM

NLS Pharmaceutics Ltd. (NASDAQ:NLSP, NLSPW)))) ("NLS" or the "Company"), a Swiss clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and

NLSP

3 minute read

Moleculin Successfully Completes First Cohort In Phase 1b/2 Trial Evaluating Annamycin In Combination With Cytarabine For The Treatment Of Acute Myeloid Leukemia

By Benzinga Newsdesk

May 2, 8:36 AM

Preliminary results demonstrate a durable complete response at starting dose level in elderly subjectPositive results from first cohort allows Company to progress to second cohort in Phase 1b portion of the Phase 1b/2

MBRX