Fda
Regener-Eyes addresses violations cited in FDA warning letter
After receiving a warning letter from the FDA on Aug. 16 citing “significant violations” related to two Regener-Eyes ophthalmic products, the company has implemented several improvements to address the concerns.
FDA grants fast track designation to ATR-04 for cancer therapy-induced skin rash
The FDA has granted fast track designation to topically applied ATR-04 for the treatment of moderate to severe epidermal growth factor receptor inhibitor-associated dermal toxicity, Azitra announced in a press release.
BLOG: For young patients with keratoconus, urgency is warranted
There has been a sea change in the care of patients with keratoconus in the U.S. since the FDA approval of iLink corneal collagen cross-linking in 2016.
Vanda’s tradipitant falls short for gastroparesis as FDA requests ‘additional studies’
The FDA has issued a complete response letter to Vanda Pharmaceuticals indicating it cannot approve the company’s new drug application seeking approval for tradipitant as a treatment for gastroparesis.
FDA grants 510(k) clearance to amyloid imaging tool
The FDA has granted 510(k) clearance to a Centiloid scaling apparatus software for positron emission tomography-based amyloid imaging to evaluate individuals for Alzheimer’s disease-related pathology.
FDA grants orphan drug designation for ATSN-201 for X-linked retinoschisis
ATSN-201 received orphan drug designation from the FDA for the treatment of X-linked retinoschisis, according to a press release from Atsena Therapeutics.
Oral achondroplasia therapy receives FDA breakthrough therapy designation
An oral medication to treat children with achondroplasia has received breakthrough therapy designation from the FDA, BridgeBio Pharma announced.
FDA clears implantable CGM with sensor that lasts up to 1 year
The FDA has cleared a continuous glucose monitoring system with an implantable sensor that can be worn for up to 1 year for adults aged 18 years and older with type 1 or type 2 diabetes, according to a press release.
Q&A: Company seeks to expand neffy FDA approval to more pediatric patients
ARS Pharmaceuticals announced its submission of a supplemental new drug application to the FDA for neffy 1 mg for the treatment of type 1 allergic reactions in children who weigh between 33 lb and 66 lb.
3D Systems, Smith & Nephew announce FDA clearance for total ankle replacement solution
3D Systems announced FDA 510(k) clearance of its total ankle patient-matched guides for use with the Salto Talaris total ankle prosthesis and the Cadence total ankle system from Smith & Nephew, according to a company press release.