The FDA approval of Lyrfigtu introduces a vital second-line treatment option for patients living with CCA and their families
Amneal said the product will launch immediately, adding another complex injectable to its growing Affordable Medicines portfolio
First U.S. ANDA submitted for Sitagliptin Tablets USP in three strengths
Lupin's Apixaban Oral Suspension 1.25 mg/mL is a liquid version of the blood-thinner apixaban
The approval marks a new treatment option for patients with advanced kidney cancer following immunotherapy
The decision follows discussions with the U.S. Food and Drug Administration (FDA) which indicated that the data submitted in support of the application do not meet the requirements for accelerated approval
The filing is based on results from the Phase III VOLGA trial
Lilly said Onswik is intended for use alongside diet and exercise to control high blood sugar
The FDA is not bound by the panel’s recommendations and will make the final regulatory decision
RINVOQ's new indication continues to build on our differentiated immunology portfolio with breadth and depth across therapeutic areas and patient populations
Glenmark Pharma clears USFDA audit for Goa plant with VAI status
The approval gives patients in Europe an alternative to frequent intravitreal eye injections
The European Commission approval follows the positive opinion adopted by the European Medicines Agency’s Committee for Medicinal Products for Human Use
Dr. Rajeev Singh Raghuvanshi outlined next phase of India’s drug regulatory reforms and also revealed plans to create 1,500 new positions to strengthen CDSCO's internal scientific capabilities
Patients receiving Inluriyo plus Verzenio had a median progression-free survival of 11.1 months
The recommendation marks a significant step toward potential approval of the therapy across the European Union
The CHMP has advised granting marketing authorisation for the drug as a 420 mg concentrate solution for infusion
If approved, efzimfotase alfa would be the first treatment intended to address both skeletal abnormalities and functional impairments across patients with HPP
The CHMP recommendation is based on data from the REAL8 clinical trial
The European Commission will now review the recommendation, with a final decision expected in the fourth quarter of 2026
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