Eyes On Novartis, Gilead, Bristol Myers As FDA Weighs Risks Vs. Benefits Of Approved CAR T-Cell Therapies
Tuesday, the FDA said it received reports of patients developing T-cell malig
FDA Investigating Serious Risk Of T-cell Malignancy Following BCMA-Directed Or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T Cell Immunotherapies
https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-investigating-serious-risk-t-cell-malignancy-following-bcma-directed-or-cd19-directed-autologous Summary of the IssueThe Food and Drug
FDA Rejects Aldeyra Therapeutics’ Dry Eye Disease Candidate, Asks For Additional Study
The FDA issued a complete response letter to Aldeyra Therapeutics Inc's (NASDAQ: ALDX) New Drug Application (NDA) of reproxalap, an investigational drug
GE HealthCare Expands On-Device Triage Capabilities Of Critical Care Suite With FDA Clearance Of Algorithm For Pneumothorax Detection, Notification, Triage and Diagnosis
As part of the latest Critical Care Suite 2.1 offering, new on-device AI helps detect and localize pneumothorax (PTX) – providing immediate notification and overlay for the presence or absence of PTX.Results from various
FDA Approves SpringWorks Therapeutics’ Lead Therapy As First For Subtype Of Soft Tissue Sarcomas
The FDA approved SpringWorks Therapeutics Inc's (NASDAQ: SWTX) Ogsiveo (nirogacestat), an oral gamma-secretase inhibitor, for adult patients with progressing desmoid tumors who
Janssen Submits Application To The European Medicines Agency For RYBREVANT In Combination With Chemotherapy For The Treatment Of Adult Patients With Advanced EGFR-Mutated Non-Small Cell Lung Cancer After Failure Of Prior Therapy
https://www.janssen.com/janssen-submits-application-european-medicines-agency-rybrevantrv-amivantamab-combinationThe submission is supported by data from the Phase 3 MARIPOSA-2 study featured in a Late-Breaking
Why Is Gastrointestinal Disease Focused-RedHill Biopharma Stock Higher Over 100% Today?
The FDA has granted five years' market exclusivity for RedHill Biopharma Ltd's (NASDAQ: RDHL) Talicia under the Generating Antibiotic Incentives Now Act Qualified Infectious Disease Product designation, as recommended by the
GRI Bio Announces FDA Clearance Of IND For Lead Program GRI-0621, A Type 1 Invariant NKT Antagonist For The Treatment Of Idiopathic Pulmonary Fibrosis
Clinical development plan leveraging 505(b)(2) regulatory pathwayInitiation of Phase 2a biomarker study on track to start before year endCurrently available treatments for IPF are limited to only two approved drugs that
Arcturus Therapeutics Receives Orphan Drug Designation From The U.S. FDA For ARCT-032, For The Treatment Of Cystic Fibrosis
First cystic fibrosis patient in Phase 1b study successfully completed two administrations of ARCT-032On track to share interim Phase 1b data in H1 2024Arcturus Therapeutics Holdings Inc. ((the "Company", "Arcturus",
Evoke Pharma Announces FDA Orange Book Listing Of New GIMOTI Patent
Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray,