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Results For "approval"

2608 News Found

Bayer receives first approval for Lynkuet in UK as treatment for vasomotor symptoms associated with menopause
Drug Approval | July 11, 2025

Bayer receives first approval for Lynkuet in UK as treatment for vasomotor symptoms associated with menopause

The UK authorization is based on positive results from the Phase III OASIS-1, -2, and -3 trials


Biocon Biologics receives MHRA UK approval for Vevzuo and Evfraxy, Denosumab Biosimilars
News | July 07, 2025

Biocon Biologics receives MHRA UK approval for Vevzuo and Evfraxy, Denosumab Biosimilars

Vevzuo is authorized for the prevention of skeletal related events in adults with advanced malignancies involving bone


Lupin receives USFDA approval for Loteprednol Etabonate Ophthalmic Gel
Drug Approval | July 02, 2025

Lupin receives USFDA approval for Loteprednol Etabonate Ophthalmic Gel

Loteprednol Etabonate Ophthalmic Gel, 0.38% is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery


Alembic announces USFDA final approval for single-dose vials
Drug Approval | June 29, 2025

Alembic announces USFDA final approval for single-dose vials

Doxorubicin Hydrochloride Liposome Injection is indicated for the treatment of Ovarian Cancer, AIDS-Related Kaposi's Sarcoma, and Multiple Myeloma


Biocon Biologics receives Health Canada approval for Yesafili
Drug Approval | June 27, 2025

Biocon Biologics receives Health Canada approval for Yesafili

The approval is based on a comprehensive package of analytical, nonclinical, and clinical data


Lupin receives USFDA approval for Prucalopride Tablets
Drug Approval | June 25, 2025

Lupin receives USFDA approval for Prucalopride Tablets

Prucalopride Tablets are indicated for the treatment of chronic idiopathic constipation in adults


Sigachi Industries gets ToR approval for API and specialty chemicals manufacturing facility in Andhra Pradesh
News | June 13, 2025

Sigachi Industries gets ToR approval for API and specialty chemicals manufacturing facility in Andhra Pradesh

The project will be instrumental in enhancing the company's API manufacturing capacity and global reach


Lupin receives tentative approval from USFDA for Oxcarbazepine ER Tablets
Drug Approval | June 09, 2025

Lupin receives tentative approval from USFDA for Oxcarbazepine ER Tablets

Oxcarbazepine ER Tablets (RLD Oxtellar XR) had estimated annual sales of US$ 206 million in the US (IQVIA MAT April 2025)


Biocon gets approval for diabetes drug Liraglutide in India
Clinical Trials | June 03, 2025

Biocon gets approval for diabetes drug Liraglutide in India

The approval is for the generic version of Victoza, indicated for the treatment of insufficiently controlled Type 2 Diabetes Mellitus