Optinose gets FDA nod for Xhance in chronic rhinosinusitis without nasal polyps
Xhance is a drug-device combination product that utilises the Exhalation Delivery System engineered to administer a topical steroid…
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18 Mar 24
Xhance is a drug-device combination product that utilises the Exhalation Delivery System engineered to administer a topical steroid…
15 Mar 24
The FDA has approved Breyanzi to treat adult patients with relapsed or refractory chronic lymphocytic leukemia or small…
15 Mar 24
The approval was based on the results from the Phase 3 RATIONALE 302 study in which Tevimbra indicated…
14 Mar 24
The approval of the IBAT inhibitor was based on findings from the Phase 3 MARCH study which included…
11 Mar 24
The approval was based on Wegovy's efficacy and safety results from the SELECT cardiovascular outcomes study in which…
08 Mar 24
The approval was based on the overall response rate (ORR) from the ROSEWOOD study in which ORR was…
04 Mar 24
The FDA approval is based on results from the Phase 3 PAPILLON study, which showed Rybrevant plus chemotherapy…
27 Feb 24
The approval allows the oral suspension to be utilised in treating CLL/ SLL, WM, and cGVHD following the…
27 Feb 24
The latest expanded indication of Biktarvy pertains to the treatment of individuals with HIV who are known or…
26 Feb 24
Simlandi is the first citrate-free, high-concentration biosimilar to be designated interchangeable with Humira in the US, and is…