Regulatory | 28 September 2026
Lupin secures tentative USFDA nod for novel Apixaban oral suspension
Lupin's Apixaban Oral Suspension 1.25 mg/mL is a liquid version of the blood-thinner apixaban
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
The approval for Kerendia (finerenone), a selective, non-steroidal mineralocorticoid receptor antagonist (nsMRA), covers finerenone at 10mg and 20mg doses
The regulator has issued Establishment Inspection report following inspection conducted in March 2025
The revised prescribing information cuts post-infusion observation from 22–24 hours to six–eight hours for the first two doses to adults with extensive-stage small cell lung cancer
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