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News about "USFDA approval"
Alembic Pharmaceuticals Secures USFDA Final Approval for Phytonadione Injectable Emulsion
Alembic Pharmaceuticals has received final USFDA approval for its Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe, used in treating and preventing vitamin K deficiency-related conditions.
USFDA Approval | 09/09/2025 | By Mrinmoy Dey
Lupin Secures US FDA Approval for Risperidone Long-Acting Injectable
Lupin has received US FDA approval for its Risperidone extended-release injectable suspension, marking the first product from its Nanomi long-acting injectables platform with 180-day CGT exclusivity.
USFDA Approval | 03/09/2025 | By Mrinmoy Dey
Piramal Pharma Solutions leveraged its CDMO expertise to help George Medicines develop WIDAPLIK, the first and only FDA-approved triple combination therapy for hypertension, combining telmisartan, amlodipine, and indapamide to effectively lower blood pressure.
USFDA Approval | 01/09/2025 | By Mrinmoy Dey
Foresee Pharmaceuticals has received US FDA approval for CAMCEVI ETM (21 mg) as a treatment for advanced prostate cancer.
USFDA Approval | 30/08/2025 | By Mrinmoy Dey
Gland Pharma Ltd. has received USFDA approval for its generic Norepinephrine Bitartrate in 5 percent Dextrose Injection, securing First-to-File status with 180 days of exclusivity in the US market.
USFDA Approval | 16/08/2025 | By Mrinmoy Dey | 101
Zydus Secures Final USFDA Approval for Diltiazem Hydrochloride Tablets
Zydus Lifesciences has received final USFDA approval to market Diltiazem Hydrochloride Tablets in 30 mg, 60 mg, 90 mg, and 120 mg dosages for the treatment of chronic stable angina and angina due to coronary artery spasm in the US.
USFDA Approval | 11/08/2025 | By Mrinmoy Dey
Hemispherian Secures FDA IND Clearance for First-in-Class Glioblastoma Therapeutic, GLIX1
Hemispherian AS has received FDA clearance for its IND application to begin a Phase 1 trial of GLIX1, a first-in-class small molecule targeting DNA repair vulnerabilities in glioblastoma and other solid tumours.
USFDA Approval | 05/08/2025 | By Mrinmoy Dey | 106
PTC Therapeutics Secures US FDA Approval for SEPHIENCE
PTC Therapeutics has received FDA approval for SEPHIENCE (sepiapterin) to treat sepiapterin-responsive phenylketonuria (PKU) in patients aged one month and older, offering a new therapy for managing this rare metabolic disorder.
USFDA Approval | 29/07/2025 | By Mrinmoy Dey | 128
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