The US FDA Approves Amgen’s Uplizna (Inebilizumab-cdon) to Treat Generalized Myasthenia Gravis

Shots: The US FDA has approved Amgen's Uplizna for the treatment of AChR & MuSK antibody positive adults with generalized myasthenia gravis (gMG) Approval was based on P-III (MINT) trial in 238 adults with gMG (190 AChR+, 48 MuSK+), where pts received 2 Uplizna loading dose followed by 2 doses/year; pts on steroids began tapering…

ByRidhi RastogiDecember 12, 2025

NEWS

GSK Reports the US FDA Approval of Blujepa for Uncomplicated Urogenital Gonorrhoea (uGC)

Shots: The US FDA has approved GSK's Blujepa (gepotidacin) for the treatment of pts (≥12yrs.; ≥45kg) with uGC caused by Neisseria gonorrhoeae who have limited or no alternative options for treatment Approval was backed by P-III (EAGLE-1) trial assessing Blujepa (2 doses × 3000mg; PO) vs ceftriaxone (500mg; IM) + azithromycin (1000mg; PO) in ~600 pts with…

ByRidhi RastogiDecember 12, 2025

NEWS

PTC Therapeutics Receives the Health Canada Approval for Sephience to Treat Phenylketonuria

Shots: Health Canada has approved PTC's Sephience (sepiapterin) for the treatment of phenylketonuria (PKU) in pts of all ages, with broad labeling for hyperphenylalaninemia in pts (≥1mos.) with sepiapterin-responsive PKU Approval was based on APHENITY study results & long-term extension data showing durable effects & favorable safety in PKU pts Sephience is a natural precursor…

ByRidhi RastogiDecember 11, 2025

NEWS

Boehringer Ingelheim Receives the NMPA Approval of Jascayd (Nerandomilast) for Progressive Pulmonary Fibrosis

Shots: The Chinese NMPA has approved Boehringer Ingelheim's Jascayd for the treatment of adults with progressive pulmonary fibrosis (PPF) Approval was based on the P-III (FIBRONEER-ILD) trial of Jascayd vs PBO, which met its 1EP of reduced FVC at Wk. 52 & showed a significant reduction in death risk Additionally, Jascayd'ssNDA for PPF is under…

ByRidhi RastogiDecember 10, 2025

NEWS

ProVerum Receives the US FDA Approval for ProVee System to Treat Benign Prostatic Hyperplasia

Shots: The US FDA has approved ProVee System for the treatment of benign prostatic hyperplasia (BPH) Approval was backed by the ProVIDE study assessing ProVee in men, which met its 1 & 2EPs, showing significant & durable symptom relief as well as improved urinary flow through 12mos. compared to sham, with preserved sexual function &…

ByRidhi RastogiDecember 10, 2025

NEWS

Zoetis’ Portela (Relfovetmab) Receives the Health Canada Approval for Osteoarthritis Pain Relief in Cats

Shots: Health Canada has approved Portela for alleviating osteoarthritis pain in cats. The company plans to launch Portela commercially in Canada and the EU in 2026 In a nine-month European trial, Portela eased OA pain and was well tolerated, including in cats with IRIS stage 1–3 kidney disease. Approved in the EU Portela is a…

ByDipanshu DixitDecember 8, 2025

NEWS

BMS Reports the US FDA Approval of Breyanzi for R/R Marginal Zone Lymphoma (MZL)

Shots: The US FDA has approved Breyanzi (lisocabtagene maraleucel; liso-cel) for the treatment of adults with r/r MZL who have received ≥2L of systemic therapy Approval was supported by MZL cohort data from the P-II (TRANSCEND FL) trial assessing Breyanzi in pts with r/r indolent B-cell non-Hodgkin lymphoma incl. follicular lymphoma & MZL In…

ByRidhi RastogiDecember 5, 2025

NEWS

Eli Lilly’s Jaypirca Receives the FDA Approval for R/R Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

Shots: The US FDA has approved label expansion of Jaypirca (pirtobrutinib; 100 & 50mg) for the treatment of adults with r/r CLL/SLL who were previously treated with a covalent BTK inhibitor & converted the accelerated approval of Dec 2023 to a full approval Label expansion was based on the P-III (BRUIN CLL-321) study assessing Jaypirca…

ByRidhi RastogiDecember 4, 2025

NEWS

The US FDA Approves Additional Presentation of Celltrion’s Omlyclo (Biosimilar, Xolair)

Shots: The US FDA has approved Omlyclo, an interchangeable biosimilar version of Xolair (omalizumab), in PFS presentation (300mg/2ml, SC) for the treatment of pts with allergic asthma, chronic spontaneous urticaria (CSU), chronic rhinosinusitis with nasal polyps (CRSwNP), & IgE-mediated food allergy Omlyclo previously received the US FDA approval in Mar 2025 for PFS injections at…

ByRidhi RastogiDecember 3, 2025

INSIGHTS+

Key Biosimilars Events of November 2025

Shots: Regulatory momentum accelerates globally, with major approvals across the US, EU, UK, and Canada for biosimilars targeting high-value biologics such as Simponi, Stelara, Perjeta, Prolia/Xgeva, Remicade, Xolair, Eylea, Lucentis, and Lantus SoloStar, strengthening patient access in immunology, oncology, ophthalmology, diabetes, and allergy/asthma Sandoz, Alvotech, Celltrion, Henlius/Organon, Teva, and others expand portfolios and market reach, including multiple EC and…

ByDipanshu DixitDecember 2, 2025

The US FDA Approves Amgen’s Uplizna (Inebilizumab-cdon) to Treat Generalized Myasthenia Gravis

GSK Reports the US FDA Approval of Blujepa for Uncomplicated Urogenital Gonorrhoea (uGC)

PTC Therapeutics Receives the Health Canada Approval for Sephience to Treat Phenylketonuria

Boehringer Ingelheim Receives the NMPA Approval of Jascayd (Nerandomilast) for Progressive Pulmonary Fibrosis

ProVerum Receives the US FDA Approval for ProVee System to Treat Benign Prostatic Hyperplasia

Zoetis’ Portela (Relfovetmab) Receives the Health Canada Approval for Osteoarthritis Pain Relief in Cats

BMS Reports the US FDA Approval of Breyanzi for R/R Marginal Zone Lymphoma (MZL)

Eli Lilly’s Jaypirca Receives the FDA Approval for R/R Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

The US FDA Approves Additional Presentation of Celltrion’s Omlyclo (Biosimilar, Xolair)

Key Biosimilars Events of November 2025

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