ANI Pharmaceuticals Announces FDA Approval for Expansion of ILUVIEN® Label
ILUVIEN now approved for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) in addition to ...
FDA approves early feasibility study of Valcare’s transcatheter device
The US Food and Drug Administration (FDA) has granted approval for Valcare Medical’s investigational device exemption ...
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, ...
FDA issues flu vaccine recommendations for 2025-26 season
The Food and Drug Administration has issued recommendations for the composition of influenza shots for the upcoming ...
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 ...
Medscape8d
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 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 ...
Fierce Pharma16h
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 ...
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 ...