Fda
FDA investigating hematologic cancer risk in kids treated with Skysona for brain disease
The FDA announced it is investigating serious health risks associated with administration of an autologous hematopoietic stem cell gene therapy for children with early active cerebral adrenoleukodystrophy, or CALD.
FDA approves Yesintek, sixth Stelara biosimilar; launch slated for February
The FDA has approved the Stelara biosimilar Yesintek for indications matching the reference product, with a commercial launch date expected for early 2025, according to a press release from Biocon Biologics.
Top news of November: FDA oral phenylephrine removal, anaphylaxis, epinephrine, more
Healio has compiled November’s most read news in asthma and allergy.
FDA clears Think Surgical miniature robotic system for use with Mobio knee system implants
Think Surgical Inc. announced it received FDA 510(k) clearance for its TMINI miniature robotic total knee arthroplasty system to be used with Mobio total knee system implants from b-One Ortho Corporation, according to a press release.
Zimmer Biomet receives FDA premarket approval for Oxford cementless partial TKR implant
Zimmer Biomet Holdings Inc. announced it received FDA premarket application supplement approval in the U.S. for its Oxford cementless partial knee replacement implant, according to a company press release.
VIDEO: Targeted therapies show ‘dramatic activity’ in cholangiocarcinoma
In this video, Lionel Aurelien Kankeu Fonkoua, MD, discusses the latest developments in targeted therapy options for cholangiocarcinoma.
FDA clears investigational new drug application for inhaled nicotine replacement therapy
The FDA has cleared an investigational new drug application for the RespiRx Nicotine Inhaler (QN-01), an inhaled nicotine replacement therapy, according to a press release.
FDA clears Think Surgical miniature robotic system for use with new implants
Think Surgical Inc. announced FDA 510(k) clearance for its TMINI miniature robotic total knee arthroplasty system to be used with LinkSymphoKnee implants from Waldemar Link GmbH & Co KG, according to a company press release.
Acuitive Technologies receives FDA 510(k) clearance of bioactive bone void filler
Acuitive Technologies Inc. announced FDA 510(k) clearance for Citrepore, a synthetic bioactive bone void filler designed to promote bone healing after orthopedic surgical procedures, according to a company press release.
FDA clears IND application for epigenetic regulator to treat idiopathic neuropathy pain
The FDA has cleared an investigational new drug application for an epigenetic regulator to treat intractable pain due to idiopathic small fiber neuropathy, according to the manufacturer.