Fresenius Kabi Launches Otulfi (Biosimilar, Stelara) in the US

Shots: Fresenius Kabi has launched Otulfi (ustekinumab- aauz) injection, a biosimilar to Stelara, developed by Formycon AG to treat mod. to sev. Crohn’s disease, ulcerative colitis, and plaque psoriasis & active psoriatic arthritis (age ≥ 6 yrs.) across the US Otulfi will be available in the US in 45 mg/0.5 mL and 90 mg/mL prefilled…

ByDipanshu DixitMarch 3, 2025

INSIGHTS+

New Drug Designations – January 2025

Shots:   PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, and NMPA The January 2025 report covers designations granted to 53 drugs and 9 medical devices, spanning 18 small molecules, 13 biologics, 13 cell and gene therapies & 9 medical devices among…

ByRidhi RastogiFebruary 28, 2025

NEWS

Alvotech and Teva Report the Regulatory Filing Acceptance for AVT06 (Biosimilar, Eylea) Across the US

Shots: The US FDA has accepted the BLA of AVT06 (2mg) for treating eye disorders, including diseases that can lead to vision loss or blindness. The regulatory approval process is expected to finish in Q4’25 AVT06/AVT29 is a recombinant fusion protein and biosimilar candidate to Eylea (aflibercept), targeting VEGF to inhibit receptor activation, neovascularization,…

ByRidhi RastogiFebruary 20, 2025

INSIGHTS+

New Drug Designations – December 2024

Shots: PharmaShots' designation report provides a concise overview of the latest drug designations by major regulatory authorities, including the FDA, EMA, MHLW and NMPA The December 2024 report covers designations granted to 43 drugs and 3 devices, encompassing 13 small molecules, 10 biologics, 7 cell and gene therapies & 3 medical devices among others Significant…

ByPrince GiriJanuary 31, 2025

INSIGHTS+

New Drug Designations – November 2024

Shots: PharmaShots' designation report provides a concise overview of the latest drug designations by major regulatory authorities, including the FDA, EMA, and NMPA The November 2024 report covers designations granted to 28 drugs and 3 devices, encompassing 9 small molecules, 6 biologics, 7 cell and gene therapies as well as 3 medical devices Significant trends…

BySaurabh ChaubeyDecember 31, 2024

NEWS

Alvotech and Teva Reports the US FDA’s Approval for the Additional Presentation of Selarsdi (Biosimilar, Stelara)

Shots: Alvotech and Teva have received the US FDA’s approval of Selarsdi’s new dosing presentation of 130mg/26mL (5mg/mL) solution in a single-dose vial for IV infusion for the same indications as Stelara (ustekinumab). It will be launched in the US during Q1’25 The US FDA, in Apr 2024, approved Selarsdi’s dosing of 45mg/0.5mL & 90mg/mL…

ByDipanshu DixitOctober 22, 2024

NEWS

Dong-A ST Reports the US FDA’s Approval of Imuldosa (Biosimilar, Stelara)

Shots: Following the BLA submission by Accord BioPharma (Intas Pharmaceuticals’ subsidiary) in 2023, the US FDA has granted approval to Imuldosa, a biosimilar version of Stelara (ustekinumab). Its MAA has also been accepted by the EMA in 2023 Intas Pharmaceuticals with its subsidiaries (Accord BioPharma & Accord Healthcare) will commercialize the biosimilar across the US,…

ByDipanshu DixitOctober 11, 2024

EXCLUSIVE

Advancing Care for Hematologic Malignancies: Chris Heery from Arcellx in a Stimulating Dialogue Exchange with PharmaShots

Shots: Arcellx’s Anito-cel, a BCMA CAR-T therapy recently got the FTD, ODD, RMAT designations by the FDA for the treatment of patients with relapsed or refractory multiple myeloma (r/rMM) Today, at PharmaShots we have Chris Heery, Chief Medical Officer at Arcellx, shedding light on Anito-Cel therapy in advancing care for multiple myeloma In late 2022,…

BySaurabh ChaubeySeptember 30, 2024

INSIGHTS+

New Drug Designations – August 2024

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. August month’s report includes designations allotted to 10 small molecules, 9 biologics, 7 cell & gene therapies, 1 vaccine, 2 radiopharmaceutical, 1 peptide, 1 antineoplastic and 2 devices In August 2024, Invenra’s INV724 received the…

BySenior EditorSeptember 25, 2024

THOUGHTSPOT

FDA Overview and Its Role in Transforming the Pharmaceutical Landscape

Have you ever considered whether the medicines you are taking, either over-the-counter (OTC) medicines or prescribed ones, are safe to consume and fulfill their proposed claims? Each medicine is regulated by an authorized body, the Food and Drug Administration (FDA). The FDA acts like a guardian of Public Health to mitigate the concerns about the…

ByEvans JamesAugust 30, 2024

Fresenius Kabi Launches Otulfi (Biosimilar, Stelara) in the US

New Drug Designations – January 2025

Alvotech and Teva Report the Regulatory Filing Acceptance for AVT06 (Biosimilar, Eylea) Across the US

New Drug Designations – December 2024

New Drug Designations – November 2024

Alvotech and Teva Reports the US FDA’s Approval for the Additional Presentation of Selarsdi (Biosimilar, Stelara)

Dong-A ST Reports the US FDA’s Approval of Imuldosa (Biosimilar, Stelara)

Advancing Care for Hematologic Malignancies: Chris Heery from Arcellx in a Stimulating Dialogue Exchange with PharmaShots

New Drug Designations – August 2024

FDA Overview and Its Role in Transforming the Pharmaceutical Landscape

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