FDA Archives - Page 107 of 220

1 minute read

Pfizer, Valneva Discontinue Certain Trial Sites For Phase 3 Study Of Lyme Disease Vaccine Candidate

February 17, 6:47 AM

Pfizer Inc (NYSE:PFE) and Valneva SE (NASDAQ:VALN) announce that Pfizer, as the study sponsor, will discontinue a significant percentage of participants in the…

PFE

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Pfizer Releases Interim Update On PARP Inhibitor Combo Therapy For Prostate Cancer, Secures FDA Priority Review

By Vandana Singh

February 16, 2:10 PM

Pfizer Inc (NYSE:PFE) announced results from the Phase 3 TALAPRO-2 study of Talzenna (talazoparib) in combination with Xtandi (enzalutamide) in 1,106…

PFE

3 minute read

Merck’s KEYTRUDA Plus Chemotherapy Significantly Improved Overall Survival Versus Chemotherapy Alone In Patients With HER2-Negative Gastric Or Gastroesophageal Junction Adenocarcinoma Regardless Of PD-L1 Expression

By Happy Mohamed

February 16, 1:31 PM

In KEYNOTE-859, KEYTRUDA combined with chemotherapy also showed statistically significant improvements in progression-free survival and objective response rate, the trial's key secondary endpoints, compared with

MRK

4 minute read

First AML Patient Transplanted With Vor Bio’s Trem-Cel Demonstrated Durable Engraftment through Multiple Mylotarg Cycles At Initial Dose Level

By Happy Mohamed

February 16, 1:01 PM

Trem-cel exhibited robust engraftment five months post-transplant through three cycles of Mylotarg Mylotarg treatment enriched CD33-negative donor hematopoiesis Second patient successfully received trem-cel

VOR

1 minute read

Intelligent Bio Solutions Has Filed A 513(G) Submission With The FDA For Its Intelligent Fingerprinting Drug Screening Cartridge

By Benzinga Newsdesk

February 16, 9:34 AM

The submission will allow Intelligent Bio Solutions to determine the most suitable FDA regulatory pathway as part of the Company's strategy for expansion into the U.S. market. The Intelligent Fingerprinting

INBS

3 minute read

Pharming Provides Update On European Medicines Agency Regulatory Review Of Leniolisib For APDS In Europe; Decided To Shift Its Assessment Of The Marketing Authorisation Application For Leniolisib To A Standard Review Timetable

By Happy Mohamed

February 16, 2:11 AM

EMA Marketing Authorisation Application for leniolisib changed to standard review timetable LEIDEN, Netherlands, Feb. 16, 2023 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the

PHAR

5 minute read

Emergent BioSolutions Reports FDA Advisory Committees’ Unanimous Vote In Favor Of NARCAN Nasal Spray, A Nonprescription Opioid Overdose Reversal Agent For Over-The-Counter Use

By Happy Mohamed

February 16, 1:35 AM

If approved by the FDA, NARCAN Nasal Spray will be the first 4 mg naloxone nasal spray switched from prescription status to over-the-counter use GAITHERSBURG, Md., Feb. 15, 2023 (GLOBE NEWSWIRE) --

EBS

2 minute read

Charles River And Purespring Therapeutics Announce Gene Therapy Manufacturing Collaboration

By Happy Mohamed

February 15, 5:43 PM

Plasmid CDMO alliance supports first gene therapy platform targeting kidney diseases Charles River Laboratories International, Inc. (NYSE:CRL) and Purespring Therapeutics, a pioneering gene therapy company

CRL

4 minute read

Axcella Announces FDA IND Clearance Supporting Regulatory Path To Registration Of AXA1125 For Long COVID Fatigue

By Happy Mohamed

February 15, 5:33 PM

Phase 2b/3 study may proceed under U.S. Investigational New Drug application Study design now accepted by U.S. and U.K. regulatory authorities Axcella to present at Long COVID forum co-sponsored by BIO and Solve

AXLA

2 minute read

Medical Cannabis For Autism: Zelira Receives $8.6M For FDA Clinical Trials For Treatment

By Joana Scopel

February 15, 4:14 PM

Zelira Therapeutics Ltd (ASX: ZLD) (OTCQB: ZLDAF), a developer of cannabinoid-based medicines, will conduct FDA Phase 2 and Phase 3 clinical trials for its HOPE-1 treatment of Autism Spectrum Disorder (ASD).

ZLDAF