FDA Archives - Page 36 of 220

2 minute read

Mirum Pharmaceuticals Announces New PDUFA Date Of March 13, 2024 For LIVMARLI For The Treatment Of Cholestatic Pruritus In Progressive Familial Intrahepatic Cholestasis

October 17, 4:37 PM

Mirum Pharmaceuticals, Inc. (NASDAQ:MIRM) today announced that the U.S. Food and Drug Administration (FDA) has extended the review of the Supplemental New Drug Application (sNDA) for LIVMARLI® (maralixibat) oral

MIRM

1 minute read

Microbot Medical Says Plans To Submit An Investigational Device Exemption Application To The FDA For A Pivotal Clinical Trial In Humans

By Benzinga Newsdesk

October 17, 9:13 AM

Microbot Medical Inc. (NASDAQ:MBOT), developer of the innovative LIBERTY® Robotic Surgical System, today announces the successful initial outcomes of using the LIBERTY Robotic Surgical System in its pivotal

MBOT

1 minute read

Microbot Medical Announces Successful Initial Outcomes Of Using Its LIBERTY Robotic Surgical System In A Pivotal Pre-Clinical Study, With 100% Usability And Technical Success And No Observed Complications

By Benzinga Newsdesk

October 17, 9:13 AM

MBOT

1 minute read

FDA Approves Merck’s Top Selling Drug, Keytruda For Expanded Use In Lung Cancer Indication

By Vandana Singh

October 17, 7:28 AM

The FDA approved Merck & Co Inc's (NYSE: MRK) Keytruda for resectable (tumors ≥4 centimeters [cm] or node-positive) non-small cell lung cancer (NSCLC) in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant

AZN

1 minute read

FDA
News

FDA Approved KEYTRUDA For Treatment Of Patients With Resectable (T≥4 cm or N+) NSCLC In Combination With Chemotherapy As Neoadjuvant Treatment, Then Continued As A Single Agent As Adjuvant Treatment After Surgery

By Charles Gross

October 16, 7:02 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 KEYTRUDA, Merck’s anti-PD-1 therapy, for the treatment of

MRK

1 minute read

AstraZeneca’s Tagrisso-Chemo Combo Under FDA Priority Review For Most Common Form Of Lung Cancer

By Vandana Singh

October 16, 10:20 AM

AstraZeneca Plc's (NASDAQ: AZN) supplemental New Drug Application for Tagrisso (osimertinib) in combination with chemotherapy has been accepted and

AZN

4 minute read

GE HealthCare Receives FDA Clearance Of Allia IGS Pulse, The Next Generation Of Image-Guided Systems Designed For Cardiac Imaging Excellence

By Benzinga Newsdesk

October 16, 10:17 AM

Building on the award-winning Allia platform for image guided therapies, the new Allia IGS Pulse was designed to improve workflow for the diagnosis and treatment of cardiovascular diseases in interventional cardiology.As

GEHC

1 minute read

Aldeyra Therapeutics Says That The FDA Stated That Reproxalap For Signs And Symptoms Of Dry Eye Disease Does Not Appear To Have Data To Support The Clinical Relevance Of The Ocular Signs To Support The Dry Eye Indication – 8K

By Benzinga Newsdesk

October 16, 8:11 AM

https://www.sec.gov/ix?doc=/Archives/edgar/data/1341235/000119312523256532/d760002d8k.htm In subsequent communications between Aldeyra and the FDA, Aldeyra has submitted responses to the FDA that Aldeyra believes to be

ALDX

1 minute read

FDA OKs Pfizer’s New Bowel Disease Drug, Analysts Predict Peak Sales Of $3B A Year

By Vandana Singh

October 13, 12:26 PM

The Food and Drug Administration (FDA) approved Pfizer Inc's (NYSE: PFE) Velsipity (etrasimod), an oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator for adults with moderately to severely active

BMY

2 minute read

Catalyst Pharmaceuticals Announces FDA Acceptance Of The Supplemental New Drug Application For FIRDAPSE

By Benzinga Newsdesk

October 13, 8:05 AM

The sNDA Seeks to Increase the Indicated Maximum Daily Dose for FIRDAPSE to 100mg for the Treatment of Lambert-Eaton Myasthenic Syndrome U.S. FDA Assigned Target Action Date of June 4, 2024CORAL GABLES, Fla., Oct.

CPRX