Ipsen gets Bylvay FDA approval for cholestatic pruritus in Alagille syndrome
The US Food and Drug Administration (FDA) has granted approval to French biopharmaceutical company Ipsen for Bylvay (odevixibat) for the treatment of cholestatic pruritus in ... Read More
FDA greenlights Granules India’s Metoprolol Succinate ER tablets
Granules India Limited announced its receipt of US Food and Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA) of Metoprolol Succinate Extended-Release ... Read More
Caplin Point to tap into $35m market after FDA approval for NIMBEX generic
Caplin Steriles, a subsidiary of India's Caplin Point Laboratories, has obtained final approval from the US Food and Drug Administration (FDA) for its generic version ... Read More
AVATAR MEDICAL virtual reality surgical planning solution gets FDA clearance
French medtech startup AVATAR MEDICAL announced that its virtual reality (VR) surgical planning solution has received 510(k) clearance from the US Food and Drug Administration ... Read More
Lupin obtains FDA approval for generic version of Ocaliva Tablets
Indian pharmaceutical company Lupin has announced its approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Obeticholic ... Read More
Lupin receives FDA approval for seizures medication Diazepam Rectal Gel
Lupin announced that its subsidiary Novel Laboratories has received approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application for ... Read More
Caplin Point Laboratories’ sterile injectable site completes FDA inspection
Caplin Point Laboratories, an Indian pharmaceutical company, has announced that the US Food and Drug Administration (FDA) has concluded its Good Manufacturing Practices (GMP) and ... Read More
GE HealthCare’s Precision DL bags FDA clearance to revolutionize PET/CT performance
GE HealthCare has announced the US Food and Drug Administration (FDA) 510(k) clearance of Precision DL, a deep learning-based image processing software. This new addition ... Read More
Concept Medical gets FDA IDE approval for MagicTouch PTA for Superficial Femoral Arteries
Concept Medical has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for its Sirolimus Coated Balloon (SCB) MagicTouch PTA ... Read More
Pulse Medical μFR system gets FDA breakthrough status for pan-vascular diagnosis
Pulse Medical Technology has announced that its fourth-generation μFR system has received breakthrough device designation from the US Food and Drug Administration (FDA) for pan-vascular ... Read More