FDA Archives - Page 37 of 220

2 minute read

Vigil Neuroscience, Inc. Has Received A Response Letter From The FDA Regarding The Partial Clinical Hold On Its Drug VG-3927, Stating That Additional Non-Clinical Data Is Needed To Exceed The Maximum Exposure Limit In The Phase 1 Trial

October 12, 4:15 PM

- SEC FilingOn Thursday, October 12, 2023, Vigil Neuroscience, Inc. (the "Company") provided an update on the Company's small molecule TREM2 agonist, VG-3927. The Company announced that it received the 30-day

VIGL

2 minute read

Reynolds American’s Vaping Products Faces FDA Hurdle, Raises Concerns Over Youth Appeal

By Vandana Singh

October 12, 1:45 PM

The FDA has reportedly ordered Reynolds American to stop selling menthol-flavored versions of its Vuse Alto e-cigarette.

BTAFF

2 minute read

BAT Expresses Disappointment At FDA Marketing Denial Order For Vuse Alto Menthol And Mixed Berry And Will Immediately Seek A Stay Of Enforcement

By Benzinga Newsdesk

October 12, 12:23 PM

The company will immediately challenge the FDA issued Marketing Denial Orders (MDOs) seeking a stay of enforcementFDA decision will serve to deny US adult smokers access to reduced risk*† productsThis decision flies

BTI

3 minute read

FDA Denies Marketing of Six Flavored Vuse Alto E-Cigarette Products Following Determination They Do Not Meet Public Health Standard

By Benzinga Newsdesk

October 12, 11:41 AM

Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) to R.J. Reynolds Vapor Company for six flavored e-cigarette products under its Vuse Alto brand. This includes three menthol-flavored and three mixed berry-flavored products, with each flavor being offered in three nicotine strengths.

1 minute read

Inovio Stock Continues To Surge: What’s Going On?

By Adam Eckert

October 11, 9:07 AM

Inovio Pharmaceuticals Inc (NASDAQ: INO) shares are trading higher again on Wednesday after surging more than 40% on Tuesday after the FDA said it can use data from the completed Phase 1/2 trial of INO-3107 to submit a Biological License Application (BLA)

INO

2 minute read

Why Is Genetic Disease-Focused Alnylam Pharmaceuticals Stock Trading Lower Today?

By Vandana Singh

October 9, 11:05 AM

The FDA has issued a Complete Response Letter (CRL) to Alnylam Pharmaceuticals Inc's (NASDAQ: ALNY) supplemental New Drug Application (sNDA) for patisiran for cardiomyopathy of transthyretin-

ALNY

3 minute read

ARS Pharmaceuticals Announces Scheduling Of A Type A Meeting With The U.S. FDA By The End Of October For neffy (Epinephrine Nasal Spray)

By Benzinga Newsdesk

October 6, 9:04 AM

ARS Pharmaceuticals, Inc. (NASDAQ:SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, today

SPRY

1 minute read

Philips’ Ventilator Device Recall Faces FDA’s Continued Discontent Pressure

By Vandana Singh

October 6, 9:01 AM

In its latest update on Koninklijke Philips NV's (NYSE: PHG) Respironics' June 2021 recall of certain CPAP, BiPAP, and ventilator devices, the FDA highlights ongoing concerns about the potential health risks from the

PHG

1 minute read

FDA Adcomm Gives Thumbs Down To Amgen’s Lumakras For Advanced Form Of Lung Cancer

By Vandana Singh

October 6, 8:59 AM

FDA advisers concluded that the data from a late-stage trial lacked the requisite reliability to endorse the traditional approval of Amgen Inc's (NASDAQ: AMGN) Lumakras for patients afflicted with an advanced

AMGN

2 minute read

Lab-Developed Tests Under FDA Scrutiny: What It Means For Startups

By Vandana Singh

October 5, 9:06 AM

A proposed regulatory shift has injected uncertainty into the laboratory-testing market just as startups advance various tests to detect diseases sooner and personalize treatments.

AGNG