Sunday, February 23, 2020

Sunday, February 23, 2020

Latest News

JANSSEN: Submits Application to U.S. FDA Seeking First-in-Class Approval of TREMFYA® (guselkumab) for Treatment of Adults with Active Psoriatic Arthritis

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking first-in-class approval of TREMFYA® (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA).

&&& Science group calls FDA fast-track approval of nasal spray shocking

The Center for Responsible Science (CRS) said it is shocking that the Federal Drug Administration (FDA) granted fast-track approval for a nasal spary based on a two-day study of 30 trial participants because it was fast-acting and later declined to label the drug fast-acting on approval.

JENKINS EYE CARE: Offers First and Only FDA-approved Trifocal Lens: AcrySof IQ PanOptix Trifocal IOL

Ophthalmological surgeons Tyrie Jenkins, M.D. and Jeffrey Peterson, M.D., Ph.D., of Jenkins Eye Care, now offer cataract patients a trifocal lens that provides a combination of near, intermediate and distance vision.

AMNEAL PHARMACEUTICALS: Announces Approval of Generic Version of Amicar®

Company granted 180 days of exclusivity under FDA Competitive Generic Therapy approval pathway

Doctors see good things with new scoliosis treatment recently approved by FDA

A doctor based at Johns Hopkins in Baltimore sees the new treatment for scoliosis recently approved by the U.S. Food and Drug Administration as a viable option for young patients.

Drawbridge Health's new blood collection device receives 510(k) clearance

Drawbridge Health received 510(k) clearance from the Food and Drug Administration for its’ OneDraw A1C Test System on Aug. 22.

Super antioxidant Ergothioneine achieves GRAS status

The super antioxidant called ergothioneine or ErgoActive by ingredient supplier and manufacturer Blue California has achieved Generally Recognized as Safe (GRAS) status from the Food and Drug Administration (FDA) under its intended conditions of use.

FDA approves new treatment for scoliosis

The U.S. Food and Drug Administration approved an innovative treatment for scoliosis last week and it happens to have a fancy nickname. It’s called The Tether and it provides a fusion-less alternative for young patients requiring surgery.

AKORN: Receives FDA Approval for Azelastine Hydrochloride Nasal Spray, 0.15%

Akorn, Inc. (Nasdaq: AKRX), a leading specialty generic pharmaceutical company, announced that it received a new Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for Azelastine Hydrochloride Nasal Spray, 0.15%. The product is manufactured at Akorn’s Amityville, New York manufacturing facility.

US WORLDMEDS: FDA Approves US WorldMeds' MYOBLOC® (rimabotulinumtoxinB) Injection for Chronic Sialorrhea

MYOBLOC is the only approved botulinum toxin for chronic sialorrhea that provides significant results in as early as one week(1),(2)

Eylea Injection Prefilled Syringe approved by FDA

The Eylea Injection Prefilled Syringe received the Chemistry, Manufacturing and Controls Prior-Approval Supplement by the Food and Drug Administration (FDA), according to a statement released by Regeneron Pharmaceuticals Inc.

FDA Health News