Repurposed FDA-approved drug could help treat high-grade glioma
High-grade glioma, an aggressive form of pediatric and adult brain cancer, is challenging to treat given the tumor location, ...
Trump’s FDA and NIH picks clear committee, teeing up final Senate confirmation
The Senate Health, Education, Labor, and Pensions Committee approved Dr. Jayanta Bhattacharya’s nomination to be NIH director ...
Managed Healthcare Executive1d
FDA Approves First Generics of Xarelto
Two companies have received approved for a generic of the 2.5 mg tablet of anticoagulant rivaroxaban, which is used to reduce ...
The Manila Times4d
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 ...
Medscape7d
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 ...
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 — ...
Fierce Pharma8h
Amid Vafseo's US launch, Akebia plots phase 3 study to grow CKD anemia med's reach
Despite finally winning a hard-fought FDA approval for its chronic kidney disease (CKD) anemia drug Vafseo last year, Akebia ...
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 Pharma3d
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 Times7d
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.
Jaguar Health Reports Approval of All Proposals at March 2025 Special Meeting of Stockholders
Jaguar expects first results in Q2 2025 of proof-of-concept investigator-initiated trials of crofelemer for the rare diseases short bowel syndrome with intestinal failure and microvillus inclusion dis ...
Yahoo Finance4d
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 ...