Category archives for: FDA News

Barbecue Basics: Tips to Prevent Foodborne Illness

Barbecuing with friends and family is a warm-weather treat. Help keep bacteria at bay with these food safety tips.

Tips to Stay Safe in the Sun: From Sunscreen to Sunglasses

The U.S. Food and Drug Administration is continuing to evaluate sunscreen products to help protect consumers from sunburn. Because certain sunscreens can help prevent skin cancer caused by the sun when used as directed with other sun protection measures, it’s important to know how to use them properly. Also learn about other ways to protect […]

FDA Approves Bevyxxa (betrixaban) for Hospital and Extended Duration Prevention of Venous Thromboembolism (VTE) in Acutely Ill Medical Patients

SOUTH SAN FRANCISCO, Calif., June 23, 2017 (GLOBE NEWSWIRE) — Portola Pharmaceuticals Inc.® (Nasdaq:PTLA) today announced the U.S. Food and Drug Administration (FDA) has approved Bevyxxa (betrixaban), the first and only anticoagulant for hospital…

FDA Approves Haegarda – First Subcutaneous C1 Esterase Inhibitor for Hereditary Angioedema

June 22, 2017 — The U.S. Food and Drug Administration today approved Haegarda, the first C1 Esterase Inhibitor (Human) for subcutaneous (under the skin) administration to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients….

Tattoo Removal: Options and Results

How hard is it to remove a tattoo? What processes are used? Is it painful?

FDA Approves Mydayis (mixed salts of a single-entity amphetamine product) – A New Once-Daily Option for ADHD

Lexington, Mass., USA – June 20, 2017 – Shire plc (LSE: SHP, NASDAQ: SHPG) announced today that the U.S. Food and Drug Administration (FDA) has approved Mydayis (mixed salts of a single-entity amphetamine product), a once-daily treatment…

Neos Therapeutics Announces FDA Approval of Cotempla XR-ODT (methylphenidate) Extended-Release Orally Disintegrating Tablets for the Treatment of ADHD in Patients 6 to 17 Years Old

DALLAS and FORT WORTH, Texas, June 19, 2017 (GLOBE NEWSWIRE) — Neos Therapeutics, Inc. (Nasdaq:NEOS), a pharmaceutical company focused on developing, manufacturing and commercializing innovative extended-release (XR) products using its proprietary…

Caution: Bodybuilding Products Can Be Risky

Are all bodybuilding products safe to use? The FDA says no and explains why.

Melinta Therapeutics Announces FDA Approval of Baxdela (delafloxacin) for Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

NEW HAVEN, Conn, June 19, 2017 – Melinta Therapeutics, a privately held company focused on discovering, developing, and commercializing novel antibiotics to treat serious bacterial infections, announced today that the U.S. Food and Drug…

Adamis Pharmaceuticals Receives FDA Approval for Symjepi (epinephrine) Pre-Filled Syringe

SAN DIEGO, June 15, 2017 (GLOBE NEWSWIRE) — Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) (“Adamis”) today announced that the U.S. Food and Drug Administration (“FDA”) has approved Adamis’ EPINEPHRINE INJECTION, USP, 1:1000 (0.3 mg…

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