The listing covers the first test capable of detecting Ebola Bundibugyo virus disease by identifying its genetic material in blood samples
Sobi said it will request a meeting with the FDA to review the feedback
The approval is based on results from the pivotal Phase 3 KEYNOTE-905 trial
Backed by Phase 3 trial showing 24% lower risk of progression
CDSCO-approved targeted therapy expands precision oncology options for patients with RET-driven lung, thyroid, and other advanced solid tumours
Approval makes it the first and only therapy in the EU indicated for both acute and chronic hepatitis C, supported by Phase 3 data
The filing is backed by positive Phase 3 results recently published in JAMA Neurology
The FDA has granted Priority Review, setting a target decision date of 9 October 2026, potentially accelerating access to a new treatment option for a subset of patients with high-risk colon cancer characterized
Through the transaction, Aurobindo USA will expand its product portfolio in this segment while gaining a U.S.-based manufacturing facility
The expanded approval covers children and teens with chronic conditions that increase vulnerability to pneumococcal infections
Company becomes sole first applicant for 45 mg strength, positioning itself for potential 180-day generic exclusivity in the US market
The newly approved treatment, SKINVIVE by JUVÉDERM, is now the first and only hyaluronic acid injectable cleared specifically for improving neck appearance
Company introduces bioequivalent version of Edarbi for hypertension treatment following U.S. FDA approval; product recorded annual U.S. sales of USD 53.5 million
The approval clears the company to market a generic version that is therapeutically equivalent to Retin-A Cream
Approval is based on results from the phase 3 OASIS 4 clinical trial
Company may qualify for 180-day generic exclusivity as sole first applicant for Bayer’s Vitrakvi capsules in the U.S.
Approval expands treatment options for patients with unresectable or metastatic HER2-positive breast cancer
Broadening access for children & patients with inhibitor-complicated hemophilia
Ranluspec is the only interchangeable ranibizumab biosimilar approved in the United States in both vial and pre-filled syringe (PFS) presentations
Approval for generic version of Xeljanz enables immediate launch and strengthens Aurobindo’s U.S. portfolio with its 586th ANDA approval
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