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News about "USFDA"
Ventris Medical's Backpack Bone Graft Systems Secure FDA 510(k) Clearance
Backpack® represents a new class of biomaterials designed for the optimisation of cell proliferation and bone formation and is used in orthopedic and spinal fusion procedures.
Usfda | 10/01/2025 | By Abha
Shanghai MicuRx's MRX-5 Receives FDA Orphan Drug Designation for NTM Infections
MRX-5 is a novel benzoxazole antibiotic developed for treating mycobacteria infections, particularly infections caused by non-tuberculous mycobacteria (NTM).
USFDA | 03/01/2025 | By Abha
NRx Pharmaceuticals Advances NRX-100 NDA Submission to FDA for Suicidal Depression Treatment
NRX-100 was initially granted Fast Track Designation in 2017 for use in combination with NRX-101 (D-cycloserine/lurasidone) for the treatment of suicidal bipolar depression.
USFDA | 01/01/2025 | By Abha
Alembic Pharmaceuticals Bags USFDA Final Approval for Diltiazem Hydrochloride Capsules
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Cardizem CD Extended-Release Capsules, 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg, of Bausch Health US, LLC.
USFDA | 12/11/2024 | By Aishwarya
Zydus Gets Final Approval from USFDA for Scopolamine Transdermal System
Scopolamine Transdermal System is indicated to prevent nausea and vomiting after anaesthesia, narcotic pain medicines, and surgery.
USFDA | 31/08/2024 | By Aishwarya | 102
Alembic Gets FDA Approval for Betamethasone Valerate Foam
Betamethasone valerate foam, 0.12 percent, is a medium potency topical corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp.
USFDA | 27/08/2024 | By Aishwarya | 155
Rusan Pharma API Plant in Ankleshwar Gets USFDA GMP Approval
Rusan Pharma has announced that the United States Food and Drug Administration (USFDA) has granted Good Manufacturing Practice (GMP) approval for its Active Pharmaceutical Ingredient (API) facility in Ankleshwar (Gujarat, India).
USFDA | 23/07/2024 | By Aishwarya | 127
Terumo BCT Receives FDA Clearance for Innovative Rika Plasma Donation System with iNomi Nomogram
This development marks a key advancement in plasma collection technology, allowing for the determination of plasma collection volume based on an individual donor's height, weight, and hematocrit level at the time of donation.
USFDA | 13/05/2024 | By Abha | 385
4C Medical's AltaValve System Granted Breakthrough Device Designation by FDA
The FDA has granted the AltaValve System Breakthrough Device designations for two therapeutic indications.
USFDA | 09/05/2024 | By Abha | 245
Single Pass Receives FDA Clearance for Kronos Biopsy Closure Device
Under the leadership of Bill Colone and the Board of Directors, the Single Pass team collaborated with their contract manufacturing partner, M4D, located in Lake Forest, CA, to bring the Kronos device to market.
USFDA | 30/04/2024 | By Abha | 197
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