FDA Archives - Page 122 of 220

2 minute read

What’s Going On With Biogen Stock Today?

December 29, 3:57 PM

Biogen Inc (NASDAQ: BIIB) shares traded higher Thursday morning before pulling back. Reports indicate that the FDA's process for approving Biogen's Alzheimer's drug Aduhelm was filled with "irregularities."

BIIB

1 minute read

Now That FDA Approved TG Therapeutics Multiple Sclerosis Treatment, Analyst Are Boosting Price Targets

By Vandana Singh

December 29, 3:47 PM

Wednesday, the FDA approved TG Therapeutics Inc's (NASDAQ: TGTX) Briumvi (ublituximab-xiiy) for relapsing forms of multiple sclerosis (RMS).

TGTX

1 minute read

FDA
News

FDA Site Shows Approval For MediWound’s NexoBrid

By Benzinga Newsdesk

December 29, 2:11 PM

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761192

MDWD

1 minute read

FDA
News

FDA Faulted for Working Improperly With Biogen Before Clearing Alzheimer’s Drug

By Benzinga Newsdesk

December 29, 2:04 PM

https://www.wsj.com/articles/biogen-aduhelm-fda-approval-congressional-investigation-11672333482

BIIB

1 minute read

FDA
News

Abbott Highlights Launch Of World’s Smallest Implantable, Rechargeable Spinal Cord Stimulation System For Chronic Pain

By Benzinga Newsdesk

December 29, 10:14 AM

https://www.accesswire.com/733557/Abbott-Launches-the-Worlds-Smallest-Implantable-Rechargeable-Spinal-Cord-Stimulation-System-for-Chronic-Pain

ABT

1 minute read

FDA
News

Heron Therapeutics Announces Filing Of An Efficacy Supplement For Zynrelef

By Benzinga Newsdesk

December 29, 10:01 AM

- Supplemental New Drug Application Submitted Requesting Expansion of Indication to Broadly Cover Soft Tissue and Orthopedic Surgical Procedures - - Omnibus Spending Bill (H.R. 2617) Includes Provision to Provide

HRTX

1 minute read

FDA
News

Hoth Therapeutics Announces FDA Acceptance Of IND Application For HT-001 For Treatment Of Cancer Disorders Associated With Epidermal Growth Factor Receptor (EGFR) Inhibitor Therapy

By Benzinga Newsdesk

December 29, 9:47 AM

Hoth Therapeutics, Inc. (NASDAQ:HOTH), a patient-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted an Investigational New Drug (IND) application for the

HOTH

1 minute read

TransCode Therapeutics Announced FDA Authorization to Proceed with First-In-Human Clinical Trial

By Charles Gross

December 29, 9:02 AM

TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA Oncology Company™ committed to more effectively treating cancer using RNA therapeutics, announced today that it has received written authorization from the U.S.

RNAZ

1 minute read

Pfizer Announces Top-Line Results From Phase 3 Study Of Hemophilia B Gene Therapy Candidate; Study Met Primary Endpoint

By Bill Haddad

December 29, 7:50 AM

The BENEGENE-2 study met its primary endpoint of non-inferiority and superiority in the annualized bleeding rate (ABR) of total bleeds post-fidanacogene elaparvovec infusion versus prophylaxis regimen with Factor IX

PFE

10 minute read

TG Therapeutics Announces FDA Approval Of BRIUMVI; Company To Host Conference Call On Thursday, December 29, 2022 At 8:30 Am ET

By Benzinga Newsdesk

December 28, 2:49 PM

BRIUMVI is the first and only anti-CD20 monoclonal antibody approved for patients with relapsing forms of multiple sclerosis that can be administered in a one-hour infusion twice-a-year following the starting dose U.S. Commercial launch expected Q1 2023 Company to host conference call on Thursday, December 29, 2022 at 8:30 AM ET

TGTX