U.S. Food and Drug Administration Press Releases - EIN Presswire

Published on December 30, 2024 - 18:00 GMT

X3 500K GOLD EDITION may be harmful due to hidden drug ingredients

[12-27-2024] The Food and Drug Administration is advising consumers not to purchase or use X3 500K GOLD EDITION, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores. FDA laboratory analysis confirmed …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 30, 2024 - 18:00 GMT

The Goat may be harmful due to hidden drug ingredient

[12-27-2024] The Food and Drug Administration is advising consumers not to purchase or use The Goat, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores. FDA laboratory analysis confirmed that The Goat …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 30, 2024 - 18:00 GMT

RIGIDRX may be harmful due to hidden drug ingredient

[12-27-2024] The Food and Drug Administration is advising consumers not to purchase or use RIGIDRX, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores. FDA laboratory analysis confirmed that RIGIDRX …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 30, 2024 - 18:00 GMT

Natural MiracleZEN Platinum 70000 may be harmful due to hidden drug ingredients

[12-27-2024] The Food and Drug Administration is advising consumers not to purchase or use Natural MiracleZEN Platinum 70000, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores. FDA laboratory analysis …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 30, 2024 - 16:16 GMT

7 Things to Know About How You Can Find CDER’s Drug Safety Information

In this Internet Age, we often go online for medical and health-related information. But not all this information is reliable, including information about medications. There are many false statements and conclusions shared online. The popularity of social …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 30, 2024 - 14:40 GMT

FDA D.I.S.C.O. Burst Edition: FDA approval of Bizengri (zenocutuzumab-zbco) for Treatment of adults with advanced unresectable or ...

Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 27, 2024 - 22:15 GMT

FDA Roundup: December 27, 2024

For Immediate Release: December 27, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA announced recommended changes to labeling for transmucosal buprenorphine products …

Distribution channels: Food & Beverage Industry, Healthcare & Pharmaceuticals Industry

Published on December 27, 2024 - 20:18 GMT

Braga Fresh Issues Voluntary and Precautionary Advisory Due to Possible Health Risk

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Food & Beverage Industry

Published on December 27, 2024 - 19:49 GMT

Combined Food and Drug Administration and Sponsor Oncologic Drugs Advisory Committee Briefing Document

Docket Number: FDA-2024-D-4490 Issued by: Guidance Issuing Office Oncology Center of Excellence The FDA is announcing the availability of a draft guidance for industry entitled “Combined FDA and Sponsor Oncologic Drugs Advisory Committee (ODAC) Briefing …

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Published on December 27, 2024 - 19:39 GMT

Gardners Candies Issues Allergy Alert on Undeclared Tree Nuts in Cappuccino Meltaway® Bars and Gardners Meltaway Treat Boxes ...

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Food & Beverage Industry

Published on December 27, 2024 - 18:52 GMT

Drug Trials Snapshots - HYMPAVZI

HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “ …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 27, 2024 - 18:52 GMT

FDA approves nivolumab and hyaluronidase-nvhy for subcutaneous injection

On December 27, 2024, the Food and Drug Administration approved nivolumab and hyaluronidase-nvhy (Opdivo Qvantig, Bristol Myers Squibb Company) for subcutaneous injection across approved adult, solid tumor nivolumab (Opdivo, Bristol Myers Squibb Company) …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 27, 2024 - 14:26 GMT

Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices

GUIDANCE DOCUMENT Draft Level 1 Guidance Not for implementation. Contains non-binding recommendations. This guidance is being distributed for comment purposes only. Submit Comments by 02/28/2025 Although you can comment on any guidance at any time (see 21 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 27, 2024 - 14:26 GMT

E6(R3) Good Clinical Practice: Annex 2

Docket Number: FDA-2024-D-5601 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “E6(R3) Good Clinical …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 27, 2024 - 14:26 GMT

M15 General Principles for Model-Informed Drug Development

Docket Number: FDA-2024-D-5580 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 26, 2024 - 22:09 GMT

Rhino 69 Gummy may be harmful due to hidden drug ingredient

[12-26-2024] The Food and Drug Administration is advising consumers not to purchase or use Rhino 69 Gummy, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores. FDA laboratory analysis confirmed that …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 26, 2024 - 22:09 GMT

Lucky Guy Platinum 18000 may be harmful due to hidden drug ingredient

[12-26-2024] The Food and Drug Administration is advising consumers not to purchase or use Lucky Guy Platinum 18000, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores. FDA laboratory analysis …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 26, 2024 - 21:35 GMT

MRESVIA

STN: 125796 Proper Name: Respiratory Syncytial Virus Vaccine Tradename: MRESVIA Manufacturer: ModernaTX, Inc. Indication: Active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 26, 2024 - 17:50 GMT

FDA Proposes Rule to Require Standardized Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic ...

For Immediate Release: December 26, 2024 Today, the U.S. Food and Drug Administration (FDA) announced a proposed rule to establish and require standardized testing methods to detect and identify asbestos in talc-containing cosmetic products. This proposed …

Distribution channels: Food & Beverage Industry

Published on December 26, 2024 - 17:43 GMT

Rhino 11 Gummy may be harmful due to hidden drug ingredient

[12-26-2024] The Food and Drug Administration is advising consumers not to purchase or use Rhino 11 Gummy, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores. FDA laboratory analysis confirmed that …

Distribution channels: Healthcare & Pharmaceuticals Industry