FDA Archives - Spark Newswire

3 minute read

Desktop Health Announces First Patients Treated With FDA-Cleared CMFlex – An Off-The-Shelf 3D Printed Synthetic Bone Graft Product Pioneered By Dimension Inx On The 3D-Bioplotter

Yesterday, 4:31 PM

Chicago-based Dimension Inx, a regenerative therapeutics company, has now had its innovative CMFlex material implanted in multiple patientsCMFlex is an off-the-shelf, customizable bone graft material indicated for

1 minute read

Why Is Sleep Disorder Device Provider Vivos Therapeutics Stock Trading Higher Today?

By Vandana Singh

Yesterday, 10:14 AM

Vivos Therapeutics Inc (NASDAQ: VVOS) received FDA 510(k) clearance for treating severe obstructive sleep apnea (OSA) in adults using the Vivos' removable CARE (Complete Airway Repositioning and/or Expansion)

VVOS

1 minute read

Why Is Philips Stock Trading Lower Today?

By Vandana Singh

Yesterday, 10:12 AM

Tuesday, the FDA issued a warning to patients and healthcare providers to carefully monitor

PHG

2 minute read

Dyadic Announces Top-Line Results From Its Successful Phase 1 Clinical Trial For A First-In-Human Filamentous Fungal-Based Vaccine Candidate; Primary Endpoint Met

By Benzinga Newsdesk

Yesterday, 8:32 AM

Primary endpoint metDemonstrated safety and reactogenicity of DYAI-100 recombinant proteinC1-cell produced antigen was both safe and well-toleratedNo Serious Adverse Events reportedFinal Clinical Study Report available

DYAI

2 minute read

Eyes On Novartis, Gilead, Bristol Myers As FDA Weighs Risks Vs. Benefits Of Approved CAR T-Cell Therapies

By Vandana Singh

Yesterday, 8:30 AM

Tuesday, the FDA said it received reports of patients developing T-cell malig

BMY

2 minute read

FDA Investigating Serious Risk Of T-cell Malignancy Following BCMA-Directed Or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T Cell Immunotherapies

By Benzinga Newsdesk

November 28, 1:25 PM

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

CABA

1 minute read

FDA Rejects Aldeyra Therapeutics’ Dry Eye Disease Candidate, Asks For Additional Study

By Vandana Singh

November 28, 12:10 PM

The FDA issued a complete response letter to Aldeyra Therapeutics Inc's (NASDAQ: ALDX) New Drug Application (NDA) of reproxalap, an investigational drug

ALDX

3 minute read

GE HealthCare Expands On-Device Triage Capabilities Of Critical Care Suite With FDA Clearance Of Algorithm For Pneumothorax Detection, Notification, Triage and Diagnosis

By Benzinga Newsdesk

November 28, 11:13 AM

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

GEHC

2 minute read

FDA Approves SpringWorks Therapeutics’ Lead Therapy As First For Subtype Of Soft Tissue Sarcomas

By Vandana Singh

November 28, 7:43 AM

The FDA approved SpringWorks Therapeutics Inc's (NASDAQ: SWTX) Ogsiveo (nirogacestat), an oral gamma-secretase inhibitor, for adult patients with progressing desmoid tumors who

SWTX

5 minute read

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

By Benzinga Newsdesk

November 27, 2:36 PM

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

JNJ