Browsing Tag
US Food and Drug Administration
348 posts
Lantern Pharma gets FDA nod for Harmonic phase 2 clinical trial of LP-300
Lantern Pharma said that the US Food and Drug Administration (FDA) has authorized it to move ahead with…
Amryt gets FDA orphan drug designation for Mycapssa for carcinoid syndrome
Amryt, a commercial-stage biopharma company, has secured orphan drug designation for Mycapssa (octreotide capsules) from the US Food…
Prescient Therapeutics gets FDA orphan drug status for PTX-100 in PTCL
Prescient Therapeutics has secured the orphan drug designation for its PTX-100 compound from the US Food and Drug…
Dr. Reddy’s Laboratories launches antimuscarinic drug Toviaz generic in US
Dr. Reddy’s Laboratories has launched Dr. Reddy’s Fesoterodine Fumarate Extended-Release Tablets in the US market following the approval…
Aura Biosciences gets FDA fast track status for belzupacap sarotalocan
Aura Biosciences has secured fast track designation for belzupacap sarotalocan (AU-011) from the US Food and Drug Administration…
Ikena Oncology gets FDA fast track designation for IK-930 in mesothelioma
Ikena Oncology has secured fast track designation for IK-930 from the US Food and Drug Administration in the…
Alkem Laboratories issued FDA Form 483 for St. Louis facility
Alkem Laboratories Limited said that it has been issued Form 483 from the US Food and Drug Administration…
Alembic Pharmaceuticals gets FDA approval for Dasatinib Tablets
Alembic Pharmaceuticals has secured tentative approval for the abbreviated new drug application (ANDA) of Dasatinib Tablets, 20 mg,…
Strides Pharma gets FDA approval for Ibuprofen oral suspension
Strides Pharma Science Limited said that its stepdown fully-owned subsidiary — Strides Pharma Global Pte. Limited, Singapore, has…
PDS Biotechnology gets FDA fast track status for PDS0101
PDS Biotechnology has secured fast track designation to its PDS0101 in combination with Merck’s KEYTRUDA (pembrolizumab) from the…