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Trodelvy (sacituzumab govitecan), First-in-class medicine to treat aggressive form of breast cancer
25 October 2021
EMA has recommended granting a marketing authorisation in the European Union (EU) for Trodelvy (sacituzumab govitecan), a first-in-class medicine to treat adult patients with unresectable (cannot be removed by surgery) or metastatic triple-negative breast cancer who have received two or more prior…
Byooviz (ranibizumab-nuna), First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions
21 September 2021
The FDA has approved Byooviz (ranibizumab-nuna) as the first biosimilar to Lucentis (ranibizumab injection) for the treatment of several eye diseases and conditions, including neovascular (wet) age-related macular degeneration (nAMD), a leading cause of vision loss and blindness for Americans aged…
Astepro (azelastine hydrochloride nasal spray, 0.15%), nasal antihistamine approved for nonprescription use
18 June 2021
The FDA has approved a nasal antihistamine for nonprescription use through a process called a partial prescription to nonprescription switch. The FDA approved Astepro (azelastine hydrochloride nasal spray, 0.15%) for seasonal and perennial allergic rhinitis—commonly known as allergies—for adults…
Aduhelm (aducanumab), first new Alzheimer’s drug in 20 years.
8 June 2021
Aduhelm (aducanumab) has been approved by the FDA for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans. Aduhelm was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful…
Wegovy (semaglutide) injection – first approved drug for chronic weight management since 2014
7 June 2021
Wegovy (semaglutide) injection (2.4 mg once weekly) has been approved by the FDA for chronic weight management in adults with obesity or overweight with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol), for use in addition to a reduced…
Lumakras (sotorasib), first treatment for adult patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation called KRAS G12C
1 June 2021
The FDA has approved Lumakras (sotorasib) as the first treatment for adult patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation called KRAS G12C and who have received at least one prior systemic therapy. This is the first approved targeted therapy for…
Farxiga (dapagliflozin) Approved for the treatment of Chronic Kidney Disease
3 May 2021
The FDA has approved Farxiga (dapagliflozin) oral tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease who are at risk of disease progression. “Chronic kidney disease is an important…
Enspryng (satralizumab), new treatment for rare autoimmune disease of nerve cells
27 April 2021
EMA has recommended granting a marketing authorisation in the European Union (EU) for Enspryng (satralizumab) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adults and adolescents from 12 years of age who are positive for anti-aquaporin-4 antibodies (AQP4-IgG). NMOSD is a…
Novartis receives EU approval for Kesimpta® (ofatumumab), the first and only self-administered, targeted B-cell therapy for adult patients with relapsing multiple sclerosis
17 April 2021
The European Commission has approved Kesimpta® (ofatumumab) for the treatment of relapsing forms of multiple sclerosis (RMS) in adults with active disease defined by clinical or imaging features. Kesimpta is a targeted, precisely dosed and delivered B-cell therapy that has shown superior efficacy…