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Lungpacer Medical Secures FDA Approval for AHRF Trial
Lungpacer Medical has announced that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device ...
Botox’s biggest rival lands in the US — Leytbo said to be faster-acting and up to 30% cheaper
“In Korea, they have over 70 neurotoxin competitors,” Kim said. “Botox is considered a very good product there, but the problem is it’s expensive. So Letybo, or Botulax, is viewed as a great product — ...
Yahoo Finance3d
U.S. FDA approves Celltrion's OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR®
JERSEY CITY, N.J., March 9, 2025 /PRNewswire/ -- Celltrion today announced the U.S. Food and Drug Administration (FDA) approved OMLYCLO ® (omalizumab-igec) as the first and only biosimilar ...
Medscape6d
As Trump Administration Probes Long-Approved Medications, Could FDA Revoke Approvals?
A new federal commission will ‘investigate’ decades-old mental health as well as weight loss drugs, prompting concerns from ...
The Manila Times1d
PharmaTher Receives US FDA Approval Goal Date for Ketamine
"I am very pleased with the new FDA approval goal date of June 4, 2025 for our Ketamine drug. We are focused on solving the shortage issue of Ketamine and becoming the leading supplier of Ketamine to ...
US FDA expands use of ARS Pharma's allergic reaction nasal spray in 15-30 kg patients
The U.S. Food and Drug Administration approved the expanded use of ARS Pharmaceuticals' nasal spray for severe allergic ...
Fierce Pharma2d
Neurotech nabs FDA approval to treat rare eye disorder with cell therapy implant Encelto
With a U.S. green light for its encapsulated cell therapy technology in the bag, privately held biotech Neurotech ...
Ophthalmology Times6d
FDA approves revakinagene taroretcel-lwey (ENCELTO) for macular telangiectasia type 2
Phase 3 trials demonstrated ENCELTO significantly slowed macular photoreceptor loss in MacTel patients over 24 months.
FDA Approves Expanded Use of Eculizumab (Soliris) for Pediatric Myasthenia Gravis, Bringing New Treatment Options for Children
The Muscular Dystrophy Association (MDA) welcomes the U.S. Food and Drug Administration (FDA) approval of the expanded indication of Alexion/AstraZeneca’s eculizumab (Soliris) for pediatric patients ...
The Manila Times3d
U.S. FDA approves Celltrion's OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR®
OMLYCLO® (omalizumab-igec) is the first and only omalizumab biosimilar approved by the FDA Regulatory approval for ...
US FDA expands use of ARS Pharma's allergic reaction nasal spray in 15-30 kg patients (March 5)
Use precise geolocation data and actively scan device characteristics for identification. This is done to store and access ...