FDA Archives - Page 43 of 220

3 minute read

Vigil Neuroscience Announces Update On Its Small Molecule TREM2 Agonist Program; Company Expects To Receive Additional Details From FDA Within Next 30 Days; Will Work Closely With FDA To Address Partial Clinical Hold

September 8, 4:10 PM

- Announced VG-3927 as lead candidate to enter clinical development for potential treatment of Alzheimer's Disease -- IND for VG-3927 now open; Phase 1 clinical trial in healthy volunteers allowed to proceed with partial

VIGL

2 minute read

Citius Pharmaceuticals, Inc. Receives Regulatory Guidance From The FDA Regarding The Planned Resubmission Of The BLA For LYMPHIR; Resubmission To FDA Planned For Early 2024

By Benzinga Newsdesk

September 8, 8:02 AM

Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR) is pleased to announce the Company has received additional guidance from the U.S. Food and Drug Administration (FDA) regarding the planned

CTXR

3 minute read

Beam Therapeutics Presents Preclinical Data Highlighting Utility Of BEAM-302 To Correct An Alpha-1 Antitrypsin Deficiency Disease-Causing Mutation

By Happy Mohamed

September 7, 10:03 AM

Beam Therapeutics Inc. (NASDAQ:BEAM), a biotechnology company developing precision genetic medicines through base editing, today reported new preclinical data demonstrating the ability of its in

BEAM

2 minute read

PharmaTher Aims To Mitigate Ketamine Shortage With New FDA Application

By Lara Goldstein

September 6, 5:21 PM

Specialty biotech company PharmaTher Holdings (OTCQB: PHRRF) reported it has submitted a priority-original Abbreviated New Drug Application (ANDA) for its proprietary racemic ketamine, KETARX, t

PHRRF

4 minute read

Vaxart Announces Topline Data From The Phase 2 Challenge Study Of Its Monovalent Norovirus Vaccine Candidate; Study Met 5 Of 6 Primary Endpoints; Vaccine Was Safe And Well Tolerated With No Vaccine-related Serious Adverse Events

By Happy Mohamed

September 6, 4:30 PM

Study met 5 of 6 primary endpoints Vaccine was safe and well tolerated with no vaccine-related serious adverse events (SAEs) Vaccination led to a statistically significant reduction in infection rate, a

VXRT

2 minute read

Corvus Pharmaceuticals Confirms Planned Initiation Of Soquelitinib Phase 3 Registrational Clinical Trial In Peripheral T Cell Lymphoma Following Meeting With FDA

By Happy Mohamed

September 6, 4:29 PM

Plans to initiate soquelitinib potentially registrational Phase 3 clinical trial in Q1 2024 Company to host conference call and webcast tomorrow at 8:30 a.m. ET / 5:30 a.m. PT BURLINGAME, Calif., Sept. 06,

CRVS

1 minute read

Amneal Receives U.S. FDA Approval For Calcium Gluconate Injection; Key Injectable Currently On The U.S. FDA Shortage List; Received Competitive Generic Therapy Approval Designation

By Happy Mohamed

September 6, 4:00 PM

- Key injectable currently on the U.S. FDA shortage list - Received Competitive Generic Therapy approval designation Amneal Pharmaceuticals, Inc. (NYSE:AMRX) ("Amneal" or the

AMRX

2 minute read

‘FDA Could Greenlight New Covid Boosters As Early As Friday’ – NBC News

By Happy Mohamed

September 6, 3:02 PM

https://www.nbcnews.com/health/health-news/fda-green-light-new-covid-boosters-early-friday-rcna103379 The Food and Drug Administration plans to greenlight updated versions of the Covid booster as early as Friday,

AZN

1 minute read

FDA
News

Phase 3 MARIPOSA-2 Study Meets Dual Primary Endpoint Resulting In Statistically Significant And Clinically Meaningful Improvement In Progression-Free Survival For RYBREVANT

By Benzinga Newsdesk

September 6, 8:57 AM

https://www.jnj.com/phase-3-mariposa-2-study-meets-dual-primary-endpoint-resulting-in-statistically-significant-and-clinically-meaningful-improvement-in-progression-free-survival-for-rybrevant-amivantamab-vmjw-plus-chemo

JNJ