FDA Archives - Page 23 of 220

5 minute read

FDA Approves Expanded Indication For KEYTRUDA Plus Padcev For The First-Line Treatment Of Adult Patients With Locally Advanced Or Metastatic Urothelial Cancer

December 16, 7:38 PM

Approval is based on results from the Phase 3 KEYNOTE-A39 trial, which demonstrated a superior overall survival benefit with KEYTRUDA plus Padcev versus platinum-based chemotherapy (gemcitabine plus cisplatin or

MRK

2 minute read

Contaminated Vaccines: FDA Reportedly Finds Cleaning And Expiry Lapses At Moderna’s Massachusetts Facility

By Nabaparna Bhattacharya

December 16, 3:58 PM

The U.S. Food and Drug Administration (FDA) identified several quality control issues at the primary manufacturing facility of Moderna Inc. (NASDAQ: MRNA)

MRK

3 minute read

‘U.S. FDA Finds Control Lapses At Moderna Manufacturing Plant’ – Reuters News

By Benzinga Newsdesk

December 15, 4:54 PM

U.S. drug regulators in September found quality control lapses at Moderna's main factory including with equipment used to manufacture drug substance for its COVID-19 vaccine, according to the report obtained by Reuters

MRNA

1 minute read

FDA Approves Merck’s Drug Belzutifan For Type Of Advanced Kidney Cancer In Pretreated Cancer Patients

By Vandana Singh

December 15, 9:59 AM

The FDA approved Merck & Co Inc's (NYSE: MRK) Welireg (belzutifan), an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for adult patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and

MRK

1 minute read

FDA
News

FDA Approved Merck’s WELIREG For The Treatment Of Patients With Advanced Renal Cell Carcinoma (RCC) Following A PD-1 or PD-L1 Inhibitor And A VEGF-TKI

By Charles Gross

December 14, 8:34 PM

Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved WELIREG, an oral hypoxia-inducible factor-2 alpha (HIF-2α)

MRK

1 minute read

Federal Violations – Chewy Among Companies Selling Unapproved Animal Drugs

By Vandana Singh

December 14, 3:28 PM

The FDA has issued warning letters to Chewy Inc (NYSE:

CHWY

3 minute read

Groundbreaking Study: LSD Tartrate Reduces Anxiety Effectively, Says MindMed

By Lara Goldstein

December 14, 3:26 PM

Clinical-stage psychedelics biotech Mind Medicine (MindMed) (NASDAQ: MNMD) has published new positive topline results from its Phase 2b study on a single dose of MM-120 (LSD tartrate,) with no additional therapeutic intervention, in Generalized Anxi

MNMD

2 minute read

Abbott’s New Lab Automation System, GLP Systems Track, Receives FDA Approval, Providing Labs And Patients With Faster Results

By Benzinga Newsdesk

December 14, 10:06 AM

https://abbott.mediaroom.com/2023-12-14-Abbotts-New-Lab-Automation-System-GLP-Systems-Track-Receives-FDA-Approval-Providing-Labs-and-Patients-with-Faster-ResultsFirst automation system in the U.S. for clinical labs

ABT

2 minute read

FDA Approves Glaukos’ Eye Implant To Treat Eye Pressure In Glaucoma Patients

By Vandana Singh

December 14, 9:53 AM

The FDA approved Glaukos Corporation's (NYSE: GKOS) marketing application for a single administration per eye of iDose TR (travoprost intracameral implant) 75 mcg, a prostaglandin analog indicated for the reduction of intraocular pressure in patients with ocular hypertension or

GKOS

1 minute read

Medtronic’s PulseSelect PFA System Gets FDA Nod, Revolutionizing Atrial Fibrillation Treatment in US

By Vandana Singh

December 14, 8:39 AM

The FDA approved Medtronic plc's (NYSE: MDT) PulseSelect Pulsed Field Ablation (PFA) System for the treatment of both paroxysmal and persistent atrial fibrillation (AF), an irregular and often

MDT