FDA News

FDA Grants Priority Review to Durvalumab for Locally Advanced Unresectable NSCLC - OncLive



OncLive
 
FDA Grants Priority Review to Durvalumab for Locally Advanced Unresectable NSCLC 
OncLive
The FDA has granted a priority review to a supplemental biologics license application (sBLA) for durvalumab (Imfinzi) for the treatment of patients with stage III, unresectable non?small cell lung cancer (NSCLC), based on positive progression-free ...

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TG stumbles on FDA feedback for cancer combo - BioPharma Dive



Press Telegraph
 
TG stumbles on FDA feedback for cancer combo 
BioPharma Dive
According to the company, the FDA said using overall response rate (ORR) data from TG's GENUINE Phase 3 study of ublituximab combined with ibrutinib to obtain conditional approval would be classified as a "review issue" ? e.g., a substantive concern ...
TG Therapeutics Gives Update on FDA Meeting GuruFocus.com (blog)

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Johnson & Johnson drops sirukumab after FDA blow, cans phase 3 AML trial - FierceBiotech



FierceBiotech
 
Johnson & Johnson drops sirukumab after FDA blow, cans phase 3 AML trial 
FierceBiotech
The likelihood of J&J washing its hands of sirukumab jumped late last month when the FDA sided with its advisory committee and rejected the anti-IL-6 monoclonal antibody. Back then, J&J said it would look into what it would take to address the FDA's ...

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Generic Drug User Fees Reauthorization: A Victory for Public Health - FDA.gov (blog)



FDA.gov (blog)
 
Generic Drug User Fees Reauthorization: A Victory for Public Health 
FDA.gov (blog)
We marked an important milestone in the U.S. generic drug program on Oct. 1, 2017 ? the start of the first reauthorization of the Generic Drug User Fee Amendments (GDUFA). These fees from industry provide FDA with vital funding that advances the Agency ...

 


FDA review supports safety, efficacy claims for semaglutide - Healio



Medscape
 
FDA review supports safety, efficacy claims for semaglutide 
Healio
A preliminary review by the FDA states that the GLP-1 receptor agonist semaglutide is safe and effective for the indication of improving glycemic control in adults with type 2 diabetes, according to a briefing document released by the agency this week.
FDA Eyes Weekly Semaglutide for Diabetes as Oral Version Advances Medscape
Will Semaglutide Fly with FDA Advisors? MedPage Today
UPDATE 1-Novo Nordisk diabetes drug effective, preliminary FDA review finds Business Insider

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Press Announcements > Statement by FDA Commissioner Scott ... - FDA.gov



Press Announcements > Statement by FDA Commissioner Scott ... 
FDA.gov
Statement by FDA Commissioner Scott Gottlieb, M.D. on Baxter manufacturing recovery in Puerto Rico.

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Press Announcements > FDA clears new robotically-assisted ... - FDA.gov



Triangle Business Journal
 
Press Announcements > FDA clears new robotically-assisted ... 
FDA.gov
Today, the U.S. Food and Drug Administration cleared the Senhance System, a new robotically-assisted surgical device (RASD) that can help facilitate minimally ...
TransEnterix shares soar on FDA clearance of robotic surgery device MarketWatch
Approved: TransEnterix stock spikes on FDA clearance Triangle Business Journal

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FDA Doesn't Anticipate Safety Review in Developing Pre-DSHEA List - Natural Products INSIDER (blog)



Natural Products INSIDER (blog)
 
FDA Doesn't Anticipate Safety Review in Developing Pre-DSHEA List 
Natural Products INSIDER (blog)
Added Steven Tave, director of FDA's Office of Dietary Supplement Programs (ODSP), in an emailed statement: ?An authoritative list of pre-DSHEA dietary ingredients will not be a list of safe ingredients. It would represent only a list of ingredients ...

 


After FDA Nod, TransEnterix Preps to Bring Surgical Robot to Market - Xconomy



WRAL Tech Wire
 
After FDA Nod, TransEnterix Preps to Bring Surgical Robot to Market 
Xconomy
Pope's comments came during a Tuesday morning conference call with analysts to discuss the FDA clearance announced last Friday for the Senhance Surgical Robotic System, TransEnterix's system for minimally invasive surgery, also called laporoscopic ...
FDA OK of TransEnterix's Senhance triggers accelerated expiration of Series A Warrants; shares up 6% premarket Seeking Alpha
FDA clears minimally invasive, robotically-assisted surgical device Healio
TransEnterix Senhance Surgical Robotic System Wins FDA Nod Zacks.com
P&T Community  -WRAL Tech Wire  -Life Science Daily 
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FDA clears first 7T magnetic resonance imaging device - FDA.gov



FDA clears first 7T magnetic resonance imaging device 
FDA.gov
?The overall image quality of MRI improves with higher magnetic field strength,? stated Robert Ochs, Ph.D., director of the Division of Radiological Health in the FDA's Center for Devices and Radiological Health. ?The added field strength allows for ...

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