FDA Archives - Page 40 of 220

1 minute read

PharmaTher Is ‘One Step Closer To Being A Ketamine Leader’ Due To FDA Acceptance

September 27, 2:38 PM

The Food and Durg Administration (FDA) has accepted specialty biopharma company PharmaTher Holdings’ (OTCQB: PHRRF) new drug application for a racemic ketamine product.

PHRRF

2 minute read

Popular Weight Loss Drugs Ozempic and Wegovy Alert: FDA Adds Intestinal Blockage Warning

By Vandana Singh

September 27, 11:52 AM

In a significant development, the FDA has updated the labeling for Novo Nordisk A/S's (NYSE: NVO) Ozempic, a diabetes drug known for its weight loss side effect, to include warnings about reports of blocked intestines

LLY

1 minute read

Why Is Women Health Focused Femasys Stock Trading Higher Today?

By Vandana Singh

September 26, 9:05 AM

Femasys Inc (NASDAQ: FEMY) shares surged after the company received FDA 510(k) clearance for FemaSeed, an infertility treatment designed to deliver sperm directly to where conception occurs in a

FEMY

1 minute read

FDA Strikes Off Coherus BioSciences’ New Injector Biosimilar Treatment For Cancer Patients

By Vandana Singh

September 25, 3:35 PM

The FDA issued a Complete Response Letter regarding the Biologics License Application supplement for Udenyca Onbody, Coherus BioSciences Inc's (NASDAQ: CHRS) on-body injector (OBI) presentation of Udenyca (pegfilgrastim-cbqv), solely due to an ongoing review of inspection

AMGN

1 minute read

Why Is Neurodegenerative Disease-Focused Brainstorm Cell Therapeutics Stock Plunging Today?

By Vandana Singh

September 25, 11:49 AM

Brainstorm Cell Therapeutics Inc (NASDAQ: BCLI) shares are sinking after the FDA released briefing documents ahead of the adcomm meeting scheduled on

BCLI

2 minute read

Cybin Delivers Highest Dose Of Psilocybin Analog In Phase 2 For Major Depression

By Lara Goldstein

September 21, 10:04 PM

Clinical-stage psychedelics biotech Cybin (NYSE: CYBN) has completed enrollment in its Phase 2 study of novel deuterated psilocybin analog CYB003 for the potential treatment of Major Depressive Disorder (MDD.)

CYBN

1 minute read

Scorpion Capital Tweets “Minutes ago, the FDA replied to our Citizen Petition requesting withdrawal of approval of Harmony Biosciences’ drug Wakix. We are pleased that the FDA Is taking our concerns seriously, view the interim response as ominous for C…

By Benzinga Newsdesk

September 21, 3:50 PM

https://twitter.com/ScorpionFund/status/1704944718411362498https://scorpionreports.s3.us-east-2.amazonaws.com/FDA-2023-P-1273.pdfMinutes ago, the FDA replied to our Citizen Petition requesting withdrawal of approval of

HRMY

2 minute read

U.S. Food And Drug Administration Approves Orphan Drug Designation For Immix Biopharma NXC-201 As A Treatment For Amyloid Light Chain Amyloidosis

By Happy Mohamed

September 21, 8:55 AM

FDA Orphan Drug Designation ("ODD") qualifies one-time treatment NXC-201 for: 7 years of U.S. market exclusivity after approval Tax credits for qualified clinical testing Waiver of the Prescription Drug

IMMX

1 minute read

Genprex Inc. Receives Orphan Drug Designation For Immunogene Therapy For Treatment Of SCLC

By Happy Mohamed

September 21, 8:41 AM

Globe Newswire NEW YORK, Sept. 21, 2023 (GLOBE NEWSWIRE) -- via InvestorWire — Genprex Inc. (NASDAQ:GNPX) today announces its placement in an editorial published

GNPX

2 minute read

89bio Announces U.S. FDA Has Granted Breakthrough Therapy Designation For Pegozafermin In Nonalcoholic Steatohepatitis

By Benzinga Newsdesk

September 21, 8:09 AM

–Supported by positive data in F2/F3 and F4 NASH patients from the ENLIVEN Phase 2b trial of pegozafermin– –Discussions with regulatory agencies regarding the NASH Phase 3 program planned for the fourth quarter of

ETNB