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FDA Grants FTD to RemeGen Telitacicept for Treatment of pSS
RemeGen Co. Ltd. Has received Fast Track Designation (FTD) by the US Food and Drug Administration (FDA) for its innovative BLyS/APRIL dual-target fusion protein drug.
INTEGRA to Give Away Limited Edition EVOLVE Manual Pipette Starter Pack
INTEGRA Biosciences has announced to give away 10 custom-printed EVOLVE manual pipette starter packs that are sure to add color to any lab.
Alembic Pharmaceuticals Receives USFDA Tentative Approval for Ribociclib Tablets
Alembic has a cumulative total of 197 Abbreviated New Drug Application (ANDA) approvals from the USFDA. Among these, 170 are final approvals, while 27 are tentative approvals.
Aurobindo Pharma Expands Manufacturing Capabilities with Four New Facilities
Lyfius Pharma Private Limited, situated in the Kakinada SEZ area of Thondangi Mandal, Kakinada District, boasts an annual production capacity of 15,000 MT of Penicillin-G.
Vanda Fanapt Receives FDA Approval for Acute Treatment of Bipolar I Disorder
Vanda Pharmaceuticals Inc. has announced that the US FDA has approved Fanapt (iloperidone) tablets for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
Eko Health Announces FDA Clearance for its Low EF Detection AI
This leap in early detection marks both a significant medical innovation and a new era in the detection of cardiovascular disease.
China Medical University Hospital Develops 'AISIA' to Diagnose Acute Ischemic Stroke in 90 Seconds
The models analyze NCCT and CTP images to detect acute ischemic stroke, as well as to identify the ischemic core and penumbra. This assist physicians in making decision of acute ischemic stroke management.
Concept Medical's MagicTouch AVF Granted FDA IDE Approval for Clinical Study
The MagicTouch AVF is designed to address the challenge of repeated blockages in arteriovenous fistulas, a common occurrence in patients undergoing haemodialysis for chronic renal failure.
Abbott's i-STAT TBI Cartridge Cleared by FDA for Whole Blood Testing
This clearance enables doctors to obtain lab-quality results within 15 minutes, facilitating timely diagnosis and treatment decisions for patients with suspected concussion.
FDA Grants Approval to NEOS Cranial LOOP for CustomizedBone Use
Kelyniam Global and Fin-ceramica have announced that NEOS Surgery Cranial LOOP fixation system has received clearance from the FDA for use with Finceramica's CustomizedBone hydroxyapatite cranial implant.
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