Zydus Partners with Bioeq for US Commercialization of Nufymco (Biosimilar, Lucentis)

Shots: Zydus Lifesciences has entered into a strategic licensing, supply & commercialization agreement with Bioeq for Nufymco (ranibizumab), an interchangeable biosimilar to Lucentis, for the US market, marking an expansion of Zydus’ US biosimilar portfolio Under the agreement, Bioeq will handle development, manufacturing, registration & supply of the finished product while Zydus will lead US…

ByPrince GiriDecember 25, 2025

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Sanofi’s Wayrilz (Rilzabrutinib) Receives the EC Approval for Immune Thrombocytopenia

Shots: The EC has approved Sanofi's Wayrilz for adults with Immune Thrombocytopenia (ITP) who are refractory to other treatments Approval was based on P-III (LUNA 3) trial assessing Wayrilz (400mg, BID, PO) vs PBO in adults (n=202) with ITP over 12wks., after which 64% vs 32% achieved a durable platelet count continued for 24wks., followed…

ByRidhi RastogiDecember 24, 2025

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Novo Nordisk Reports the US FDA Approval of Oral Wegovy for Weight Management

Shots: FDA has approved Wegovy (25mg, QD, PO) for weight loss, chronic weight management & major adverse CV events risk reduction in adults with obesity/overweight; US availability expected in early Jan 2026. Regulatory filing is made to the EMA & other authorities in H2’25 Approval was based on the P-IIIb (OASIS 4) trial assessing oral…

ByRidhi RastogiDecember 24, 2025

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Incyte’s Minjuvi (Tafasitamab) Combination Gains the MHLW Approval for R/R Follicular Lymphoma (FL)

Shots: The MHLW has approved Incyte’s Minjuvi + rituximab & lenalidomide for the treatment of adults with r/r FL (Grade 1-3a) who received ≥1L of systemic therapy Approval was based on the P-III (inMIND) trial (N=654) assessing Minjuvi combination vs PBO + rituximab & lenalidomide in r/r FL or r/r nodal, splenic or extranodal MZL…

ByRidhi RastogiDecember 23, 2025

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Roche Receives the US FDA Approval of Lunsumio VELO for Subcutaneous Use in R/R Follicular Lymphoma

Shots: The US FDA has approved Roche’s Lunsumio VELO (mosunetuzumab) as an SC formulation for the treatment of adults with r/r follicular lymphoma (FL) after ≥2L of systemic therapy, under accelerated approval Approval was based on the P-I/II (GO29781) study in third-line or later FL pts, where Lunsumio VELO demonstrated an ORR of 75% and…

ByPrince GiriDecember 23, 2025

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The NMPA Approves Merck KGaA’s Pimicotinib for Tenosynovial Giant Cell Tumor (TGCT)

Shots: The NMPA has approved Merck KGaA's Pimicotinib (PO) for the treatment of adults with symptomatic TGCT, where surgical resection can lead to functional limitation or relatively severe morbidity Approval was based on the global 3-part P-III (MANEUVER) trial in TGCT pts who require systemic therapy & have not received prior anti-CSF-1/CSF-1R therapy, in which…

ByRidhi RastogiDecember 23, 2025

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Johnson & Johnson’s Tremfya (Guselkumab) Receives the EC Approval for Pediatric Plaque Psoriasis (PsO)

Shots: The EC has approved Tremfya (SC) for children (≥6yrs.) with mod. to sev. PsO, who are candidates for systemic therapy Approval was based on P-III (PROTOSTAR) trial in 120 pediatric pts, which met its co-1EPs of PASI 75 (~76% vs 20%) & IGA 0/1 (66% vs 16%) at 16wks., with ~40% vs 4% achieving IGA…

ByRidhi RastogiDecember 22, 2025

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

Shots: The US FDA has approved 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, where Jascayd significantly reduced lung function decline at Wk. 52, with FVC decreases of 86mL (18mg) & 69mL (9mg) vs 152mL with PBO, showing clinically meaningful…

ByRidhi RastogiDecember 22, 2025

NEWS

Cytokinetics Reports the US FDA Approval of Myqorzo (Aficamten) for Obstructive Hypertrophic Cardiomyopathy (oHCM)

Shots: The US FDA has approved Cytokinetics’ Myqorzo (5, 10, 15 & 20mg) for the treatment of adults with symptomatic oHCM, available in second half of Jan 2026 through a restricted program via REMS Approval was based on P-III (SEQUOIA-HCM) trial of Myqorzo, showing improved exercise capacity vs PBO at 24wks., with increased peak oxygen…

ByRidhi RastogiDecember 22, 2025

NEWS

Novo Nordisk Reports the US FDA’s NDA Submission of CagriSema for Weight Management

Shots: The U.S. FDA has accepted the NDA for Novo's CagriSema (cagrilintide 2.4mg + semaglutide 2.4mg) to support long-term weight loss & maintenance in adults with obesity or overweight & ≥1 related comorbidity, alongside lifestyle intervention NDA was supported by the P-III (REDEFINE 1) trial assessing CagriSema (QW) vs semaglutide 2.4mg alone, cagrilintide 2.4mg alone,…

ByRidhi RastogiDecember 19, 2025

Zydus Partners with Bioeq for US Commercialization of Nufymco (Biosimilar, Lucentis)

Sanofi’s Wayrilz (Rilzabrutinib) Receives the EC Approval for Immune Thrombocytopenia

Novo Nordisk Reports the US FDA Approval of Oral Wegovy for Weight Management

Incyte’s Minjuvi (Tafasitamab) Combination Gains the MHLW Approval for R/R Follicular Lymphoma (FL)

Roche Receives the US FDA Approval of Lunsumio VELO for Subcutaneous Use in R/R Follicular Lymphoma

The NMPA Approves Merck KGaA’s Pimicotinib for Tenosynovial Giant Cell Tumor (TGCT)

Johnson & Johnson’s Tremfya (Guselkumab) Receives the EC Approval for Pediatric Plaque Psoriasis (PsO)

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

Cytokinetics Reports the US FDA Approval of Myqorzo (Aficamten) for Obstructive Hypertrophic Cardiomyopathy (oHCM)

Novo Nordisk Reports the US FDA’s NDA Submission of CagriSema for Weight Management

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