Skip to content Skip to footer
Subscribe Now
Celltrion
NEWS

Celltrion’s CT-P39 (biosimilar, omalizumab) Receives the CHMP’s Recommendation for Marketing Authorization to Treat Multiple Indications 

Shots:  EMA received CHMP’s recommendation to grant marketing authorization for full-label application of Celltrion’s CT-P39, developed as a biosimilar to Xolair (omalizumab). The company expects to receive EC’s approval by early May 2024  Xolair is a monoclonal antibody approved for the treatment of various indications incl. Allergic Asthma, Nasal Polyps, and Chronic Hives. Recently, Xolair…
May 23, 2024

Read more

NEWS

Biocon’s Yesafili (Biosimilar, Eylea) Receives the US FDA’s Approval for Ophthalmology 

  Shots:  The US FDA has approved Yesafili (aflibercept-jbvf), biosimilar to Eylea, for treating neovascular (wet AMD) age-related macular degeneration as well as visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), DME & myopic choroidal neovascularization (myopic CNV)  The approval was supported by analytical, nonclinical & clinical data…
May 21, 2024

Read more

Teva and Alvotech
NEWS

Teva and Alvotech Launches Simlandi (Biosimilar, Humira) Injection Across US to Treat Multiple Indications 

Shots:  The company has launched Simlandi (citrate-free biosimilar, Humira) injection to treat RA, PsA, AS, UC, Plaque Pso, HS, uveitis, juvenile idiopathic arthritis & CD in the US  The US FDA has approved Simlandi (40mg/0.4mL) injection. Both the low & high concentrations dosing strengths are approved and marketed across the US  The approval was based…
May 20, 2024

Read more

Amgen (2)
NEWS

Amgen’s Imdelltra (Tarlatamab-dlle) Receives the US FDA’s Approval to Treat Extensive-Stage Small Cell Lung Cancer 

Shots:  The US FDA has granted accelerated approval to Amgen’s Imdelltra (DLL3-targeting bispecific T-cell engager) for treating extensive-stage small cell lung cancer (ES-SCLC) adults whose disease progressed post Pt-based CT. Full approval depends upon confirmatory trials  The approval was based on the P-II (DeLLphi-301) study assessing Imdelltra (10mg, Q2W) in SCLC patients (n=99) failing on…
May 16, 2024

Read more

NEWS

Xbrane Biopharma and STADA Team Up with Valorum Biologics for Commercializing Xlucane (Biosimilar, Ranibizumab) Across the US 

Shots:  Xbrane & STADA have signed an exclusive license agreement with Valorum Biologics to commercialize Xlucane, biosimilar of ranibizumab, across the US  As per the agreement, both companies will complete the regulatory approval process; Xbrane to handle commercial manufacturing & supply. Post approval, Valorum will take care of sales, marketing & other commercial activities of…
May 10, 2024

Read more

Azurity Pharmaceuticals
NEWS

Azurity Pharmaceuticals’ Myhibbin (Mycophenolate Mofetil) Receives the US FDA’s Approval to Treat Organ Rejection 

Shots:  The US FDA has approved Azurity Pharmaceuticals’ Myhibbin oral suspension with its commercial availability anticipated in Q2’24   Myhibbin in addition to other immunosuppressants is intended for preventing organ rejection in adults & pediatric patients (age: ≥3mos.) of allogeneic kidney, heart, or liver transplant   Mycophenolate mofetil, an antimetabolite immunosuppressant, works on the immune system of…
May 6, 2024

Read more

Load more