FDA Archives - Page 44 of 220

2 minute read

Why Lung Disease Focused Stock Insmed Is Trading Higher Today?

September 5, 12:34 PM

Insmed Incorporated (NASDAQ: INSM) shares are trading higher after the company released topline results from its Phase 3 ARISE study of ARIKAYCE in patients with newly diagnosed or recurrent nontuberculous mycobacterial (NTM) lung infection caused by Mycobacterium avium complex (MAC)

INSM

1 minute read

Cannabis Stocks Soar As Gov Health Officials Call On DEA To Reschedule Marijuana: Is Legalization In Sight?

By Maureen Meehan

August 30, 3:00 PM

The Department of Health and Human Services is recommending to the Drug Enforcement Administration that cannabis should be reclassified as a Schedule III controlled substance under federal law, according to a report by

CGC

2 minute read

Lexaria Provides Update On Investigational New Drug Application Progress With The FDA For Its Planned U.S. Phase 1b Hypertension Clinical Trial Designated As HYPER-H23-1

By Happy Mohamed

August 30, 9:24 AM

Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, is providing this update on the status of the Company's

LEXX

1 minute read

ENDRA Life Sciences’ TAEUS De Novo Submission Advances To Next Stage Of Review With FDA

By Happy Mohamed

August 30, 8:19 AM

ENDRA Life Sciences Inc.(NASDAQ:NDRA), a pioneer of imaging technologies and Thermo Acoustic Enhanced UltraSound (TAEUS®), announces that the Company's De Novo request for the TAEUS liver system has advanced to

NDRA

1 minute read

Why Is Outlook Therapeutics Stock Nosediving Today?

By Vandana Singh

August 30, 7:39 AM

Outlook Therapeutics Inc (NASDAQ: OTLK) shares are falling after the company received an FDA complete response letter regarding ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat

OTLK

2 minute read

EXCLUSIVE: Alzamend Seeks FDA Approval For Study For Upgraded Version Of Most Commonly Used Treatment For Bipolar Disorder

By Vandana Singh

August 30, 7:30 AM

Alzamend Neuro Inc (NASDAQ: ALZN) has submitted an investigational new drug (IND) application to the FDA to initiate AL001-BD01, a Phase 2A study of AL001 for bipolar disorder.

ALZN

2 minute read

Delegation from U.S. Department Of Health And Human Services, U.S. Food And Drug Administration, And Local Government Officials Visit Amneal Pharmaceuticals, Inc. Manufacturing Site In India

By Happy Mohamed

August 29, 4:09 PM

- Senior members of the U.S. Government Visit One of Amneal's 12 Manufacturing Sites Amneal Pharmaceuticals, Inc. (NYSE:AMRX) ("Amneal" or the "Company") today announced that a delegation of

AMRX

1 minute read

Bristol Myers’ Expanded Approval For Anemia Drug, Shows Superior Efficacy Over Concurrent Blood Transfusion

By Vandana Singh

August 29, 1:40 PM

On Monday, the FDA approved Bristol Myers Squibb Co's (NYSE: BMY) Reblozyl (luspatercept-aamt) for anemia without previous erythropoiesis-stimulating agent use (ESA-naïve) in adult patients with very low-to-intermediate-risk myelodysplastic syndromes (MDS) who may require regular

BMY

1 minute read

How Lawmakers Want To Stop Cronobacter Outbreaks That Spurred Baby Formula Shortage Last Year

By Vandana Singh

August 29, 1:20 PM

Under bipartisan Congressional legislation, baby formula manufacturers must notify the U.S.

ABT

2 minute read

FDA
News

Certara Simcyp Group Awarded Two New Grants From U.S. FDA; Amount Not Disclosed

By Benzinga Newsdesk

August 29, 8:27 AM

"We are proud to collaborate with the FDA in developing innovative model-informed approaches for accelerating drug development of complex generic and innovator drugs," said Rob Aspbury, President of Certara, Scientific"We are proud to collaborate with the FDA in developing innovative model-informed approaches for accelerating drug development of complex generic and innovator drugs," said Rob As

CERT