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Senores Pharma Wins US FDA Approval for Deferiprone Tablets, Launched by Dr Reddy's
Senores Pharmaceuticals has announced the approval and US launch of Deferiprone Tablets USP (500 mg and 1000 mg), to be marketed by Dr Reddy’s Laboratories Inc.
USFDA | 15/12/2025 | By News Bureau
Indoco Receives USFDA EIR for Patalganga API Manufacturing Facility
Indoco has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration for its API manufacturing facility at Patalganga following an inspection conducted in the month of September.
USFDA | 15/12/2025 | By News Bureau
Platform Technologies Drive USD 211 Billion Surge in Precision Cancer Treatment
The rapid rise of platform technologies has added USD 211 billion in value to the precision oncology landscape, with immunotherapies now accounting for more than 45 percent of global anticancer drug revenues—underscoring strong investor confidence in biologically targeted treatment approaches.
USFDA | 12/12/2025 | By Akanki
US FDA Approves Uplizna for Adults with Generalised Myasthenia Gravis
The US FDA has approved Uplizna for adults with generalised myasthenia gravis, marking a significant advancement as the first and only CD19-targeted B-cell therapy for both anti-AChR and anti-MuSK antibody–positive patients, offering durable disease control with just twice-yearly dosing.
USFDA | 12/12/2025 | By Akanki
FDA Approves Waskyra Gene Therapy for Wiskott-Aldrich Syndrome
Fondazione Telethon announced that the US FDA has approved Waskyra (etuvetidigene autotemcel), a gene therapy for Wiskott-Aldrich Syndrome (WAS), marking a milestone in both science and clinical care. The approval offers new hope for patients living with this rare immunodeficiency disorder.
USFDA | 11/12/2025 | By Akanki
Amneal Gets FDA Approval for Epinephrine Vials
The FDA has approved Amneal’s epinephrine injection in both single- and multi-dose vials, strengthening the company’s injectables portfolio with a critical medicine widely used in hospitals for emergency and perioperative care.
USFDA | 10/12/2025 | By Akanki
Ouro Medicines Receives US FDA ODD for Gamgertamig (OM336) for Immune Thrombocytopenia
Ouro Medicines has secured a second ODD from the FDA for gamgertamig (OM336), this time for immune thrombocytopenia (ITP), following an earlier designation for autoimmune hemolytic anemia (AIHA). It comes as the company completes dosing in the first cohort of its global basket trial in autoimmune cytopenias.
USFDA | 09/12/2025 | By Akanki
Virax Biolabs Closes USD 5 Million Private Placement
Virax Biolabs has closed a USD 5 million private placement, extending its cash runway into the first half of 2028 and supporting ongoing regulatory studies for its ViraxImmune platform, including long COVID and post-acute infection syndrome programmes, alongside planned FDA and MHRA submissions and platform expansion initiatives.
USFDA | 06/12/2025 | By Dineshwori
Lilly Lowers Zepbound's Single-dose Vials' Cost
Lilly has reduced the price of its Zepbound (tirzepatide) single-dose vials, reinforcing its commitment to improving affordability and expanding access for people living with obesity.
USFDA | 02/12/2025 | By Dineshwori
Ascletis Advances First Oral Triple Agonist ASC37 to Clinical Development
Ascletis has selected ASC37—its first oral GLP-1R/GIPR/GCGR triple peptide agonist—for clinical development. Using the company’s POTENT technology, ASC37 showed markedly higher oral bioavailability and drug exposure than leading agents in non-human primate studies.
USFDA | 01/12/2025 | By Dineshwori
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