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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Daiichi Sankyo Reports First Patient Dosing in P-III (DESTINY-Endometrial02) Trial of Enhertu for HER2+ Endometrial Cancer

Shots: Daiichi Sankyo has dosed the first patient with Enhertu ± radiotherapy in the P-III (DESTINY-Endometrial02) trial, conducted in collaboration with The GOG Foundation & ENGOT, with the GINECO as the lead ENGOT group The trial will evaluate the efficacy and safety of Enhertu (5.4mg/kg) ± radiotherapy vs SoC CT (carboplatin & paclitaxel) ± radiotherapy…

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

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BioMarin to Acquire Amicus Therapeutics for ~$4.8B

Shots: BioMarin has entered into a definitive agreement to acquire Amicus, strengthening BioMarin's commercial portfolio with Galafold (migalastat) for Fabry Disease & Pombiliti (cipaglucosidase alfa-atga) + Opfolda (miglustat) for Pompe Disease As per the deal, BioMarin will acquire Amicus for $14.5/share in an all-cash transaction for a total equity value of ~$4.8B; closing is expected in Q2’26 Amicus also…

ByRidhi RastogiDecember 22, 2025

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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

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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

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Daiichi Sankyo Reports the EMA’s MAA Validation of Datroway to Treat Metastatic Triple Negative Breast Cancer

Shots: The EMA has validated the Type II Variation MAA for Daiichi's Datroway (datopotamab deruxtecan) as monotx. For the 1L treatment of adults with unresectable or metastatic TNBC who are ineligible for PD-1/PD-L1 inhibitor therapy; additional regulatory filings are underway MAA was supported by the global P-III (TROPION-Breast02) trial assessing Datroway vs CT in 644…

ByRidhi RastogiDecember 19, 2025

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)

Daiichi Sankyo Reports First Patient Dosing in P-III (DESTINY-Endometrial02) Trial of Enhertu for HER2+ Endometrial Cancer

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

BioMarin to Acquire Amicus Therapeutics for ~$4.8B

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

Daiichi Sankyo Reports the EMA’s MAA Validation of Datroway to Treat Metastatic Triple Negative Breast Cancer

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