Category archives for: FDA News

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…

Breast Cancer in Men: Treatments and Genetic Counseling

Breast cancer in men tends to be diagnosed at an older age and a later stage, but is treated very similarly to breast cancer in women.

FDA Approves Gleolan (aminolevulinic acid hydrochloride) as an Optical Imaging Agent in Patients with Gliomas

June 6, 2017 – The U.S. Food and Drug Administration (FDA) has approved Gleolan [aminolevulinic acid hydrochloride (ALA HCl)] as an optical imaging agent indicated in patients with gliomas (suspected World Health Organization Grades III or IV on…

Braces Have Changed, From Metal to Tooth-Colored to Clear

FDA answers your questions about braces and how they’ve changed.

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