FDA Archives - Page 35 of 220

6 minute read

Ambrx Announces ARX517, A PSMA-Targeted ADC, Demonstrates 52% PSA50 (≥50% Reduction) And A Highly Differentiated Safety And PK Profile In Patients With mCRPC, Who Progressed On Multiple FDA-Approved Treatments

October 23, 8:10 AM

Newly published data from the Phase 1 portion of the on-going Phase 1 / 2 APEX-01 trial provide the following key points: Multiple efficacy endpoints demonstrate consistent and promising anti-cancer activity at

AMAM

3 minute read

FDA Approves BioMarin’s VOXZOGO For Children Under 5 Years With Achondroplasia

By Benzinga Newsdesk

October 20, 4:09 PM

Expanded Indication in the U.S. Now Includes Children of all ages with Achondroplasia BioMarin Pharmaceutical Inc. (NASDAQ:BMRN), a global biotechnology company dedicated to transforming lives through genetic

BMRN

3 minute read

FDA
News

Philip Morris International Submits Applications To Commercialize IQOS ILUMA Tobacco Heating System To U.S. FDA

By Benzinga Newsdesk

October 20, 4:03 PM

The applications mark the next step in the company's mission to offer adults who smoke a portfolio of innovative, scientifically substantiated nicotine alternatives that can help make America free from conventional

4 minute read

FDA Approves PENBRAYA, The First And Only Vaccine For The Prevention Of The Five Most Common Serogroups Causing Meningococcal Disease In Adolescents

By Benzinga Newsdesk

October 20, 3:36 PM

PENBRAYA™ provides the broadest serogroup coverage (meningococcal groups A, B, C, W and Y) of any meningococcal vaccine available in the U.S. and has the potential to help simplify complex vaccination schedule in

PFE

2 minute read

FDA Says Philips Respironics Recalls V60 And V60 Plus Ventilators Due To Power Management Printed Circuit Board Assemblies (PM PCBAs) Not Meeting Ventilator Standards

By Benzinga Newsdesk

October 20, 12:58 PM

https://www.einnews.com/pr_news/663151321/philips-respironics-recalls-v60-and-v60-plus-ventilators-due-to-power-management-printed-circuit-board-assemblies-pm-pcbas-not-meeting-ventilatorThe FDA has identified this as a

PHG

2 minute read

FDA Says Baker Farms Issues Voluntarily Recall On 16-Ounce Kroger Bagged Collard Greens Due To Possible Listeria Monocytogenes Contamination

By Benzinga Newsdesk

October 20, 11:58 AM

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/baker-farms-issues-voluntarily-recall-16-ounce-kroger-bagged-collard-greens-due-possible-listeria#:~:text=Bagged%20Collard%20Greens-,Company%20Announcem

1 minute read

What’s Going On With Medical Devices Focused SeaStar Medical Stock Today?

By Vandana Singh

October 19, 11:06 AM

SeaStar Medical Holding Corporation (NASDAQ: ICU) shares are trading higher on Thursday, on continued strength after the company received FDA Breakthrough Device Designation for its cell-directed Selective Cytopheretic Device (SCD).

ICU

3 minute read

FDA Grants SeaStar Medical’s Selective Cytopheretic Device Breakthrough Device Designation For Hepatorenal Syndrome

By Benzinga Newsdesk

October 18, 8:33 AM

SeaStar Medical Holding Corporation (NASDAQ:ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces receipt of U.S. Food and Drug

ICU

1 minute read

After Initial Rejection, FDA Approves Ardelyx’s Kidney Disease-Related Drug

By Vandana Singh

October 18, 8:29 AM

The FDA approved Ardelyx Inc's (NASDAQ: ARDX) Xphozah (tenapanor), the first and only phosphate absorption inhibitor, indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have inadequate response to phosphate binders or

ARDX

2 minute read

Bionomics Meets The FDA: Lead Drug Candidate For Social Anxiety Heads To Phase 3

By Lara Goldstein

October 17, 10:28 PM

Biopharma company Bionomics Ltd.

BNOX