Womed Reports the US FDA’s Approval of Womed Leaf to Treat Asherman Syndrome

Shots: The US FDA has approved the PMA application of Womed Leaf for women undergoing hysteroscopic surgery for symptomatic moderate to severe intrauterine adhesions (Asherman syndrome); commercial launch expected in early 2026 Womed Leaf was evaluated in the PREG2 trial (n=160) for mod. to sev. intrauterine adhesions, showing reduced severity of intrauterine adhesion after hysteroscopic…

ByRidhi RastogiSeptember 16, 2025

NEWS

Novocure Reports MHLW’s Approval of Optune Lua for NSCLC

Shots: Approval of Optune Lua for adults with unresectable advanced/recurrent NSCLC who progressed on Pt-based regimen, was based on P-III (LUNAR) trial assessing it with PD-1/PD-L1 inhibitors or docetaxel (n=145) vs PD-1/PD-L1 inhibitors or docetaxel alone (n=146) Trial showed an mOS (1EP) of 13.2 vs 9.9mos. in the overall population, 19 vs 10.8mos. with Optune Lua +…

ByRidhi RastogiSeptember 16, 2025

NEWS

Zoetis’ Portela (Relfovetmab) Receives the CVMP’s Positive Opinion for Osteoarthritis Pain Relief in Cats

Shots: The CVMP has recommended Portela (relfovetmab) for alleviating osteoarthritis pain in cats, with an EC decision expected in Q4’25 & commercial launch planned for 2026 Opinion was based on superior safety & efficacy in cats across trials, incl. cats with IRIS stage 1–3 kidney disease, & showed relieved osteoarthritis pain Portela is a long-acting…

ByRidhi RastogiSeptember 15, 2025

NEWS

Sanofi’s Tzield Receives the NMPA’s Approval to Delay Progression of Type 1 Diabetes

Shots: China’s NMPA has approved Tzield (teplizumab) to delay the onset of stage 3 type 1 diabetes (T1D) in adult & pediatric pts (≥8yrs.) with stage 2 T1D; regulatory review is ongoing in the EU & other regions Approval was based on the P-II (TN-10) trial assessing Tzield (QD for 14 days) vs PBO, which…

ByRidhi RastogiSeptember 10, 2025

NEWS

Medison and Ipsen’s Bylvay Receives the Health Canada’s Approval to Treat Cholestatic Pruritus in Alagille Syndrome Patients

Shots: Health Canada has approved Bylvay (odevixibat) for the treatment of cholestatic pruritus in pts (≥12mos.) with Alagille Syndrome (ALGS) Approval was based on P-III (ASSERT) trial assessing Bylvay (120µg/kg, QD) vs PBO in ALGS pts for 24wks. across North America, EU, Middle East, & Asia Pacific regions Trial met its 1EP of improved pruritus…

ByRidhi RastogiSeptember 10, 2025

NEWS

Takeda’s Vonvendi Receives the US FDA’s Approval for Adults and Children with Von Willebrand Disease

Shots: FDA has approved a label extension for Vonvendi to incl. routine prophylaxis for reducing bleeding in adults with Type 1 & 2 von Willebrand disease (VWD), & for on-demand & perioperative bleeding management in pediatric pts Approval was backed by extensive data, incl. a P-III trial in adults, a P-III trial in children, a P-IIIb continuation…

ByRidhi RastogiSeptember 8, 2025

NEWS

AbbVie’s Elahere (Mirvetuximab Soravtansine) Receives the Health Canada’s Approval to Treat Platinum-Resistant Ovarian Cancer

Shots: Health Canada has approved Elahere under priority review to treat FRα+, Pt-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after 1-3 prior treatments Approval was based on P-III (MIRASOL) trial assessing Elahere vs investigator's choice of CT in pts (n=453) to treat PROC expressing high levels of FRα, as determined using the Ventana…

ByRidhi RastogiSeptember 4, 2025

NEWS

Henlius and Organon Receive the US FDA’s Approval for Bildyos & Bilprevda (Biosimilars, Prolia & Xgeva)

Shots: The US FDA has approved Bildyos (60mg/mL) & Bilprevda (120mg/1.7mL), biosimilar versions of Amgen’s Prolia & Xgeva (denosumab) for all indications of the reference product Approval was based on extensive clinical data, incl. analytical, PK & clinical studies, which showed comparable quality, efficacy & safety of Bildyos & Bilprevda to reference denosumab In 2022,…

ByRidhi RastogiSeptember 3, 2025

NEWS

The NMPA Grants Conditional Approval to Boehringer Ingelheim’s Hernexeos for HER2-Mutant NSCLC

Shots: China’s NMPA has granted conditional approval to Hernexeos (zongertinib) for treating pts with inoperable, locally advanced or metastatic NSCLC harboring HER2 (ERBB2) mutations who have received prior systemic therapy Approval was based on P-Ib (Beamion LUNG-1) trial assessing Hernexeos alone, which showed improved ORR of 71% (N=75: 7% CR), mDoR of 14.1mos. & mPFS…

ByRidhi RastogiSeptember 1, 2025

NEWS

Sanofi’s Wayrilz (Rilzabrutinib) Receives the US FDA’s Approval for Immune Thrombocytopenia (ITP)

Shots: FDA has approved Wayrilz for adults with persistent or chronic ITP who did not respond adequately to prior therapy following approval in UAE in Jun 2025; Application under the EMA & NMPA's review Approval was based on P-III (LUNA 3) trial assessing Wayrilz (400mg, BID, PO) vs PBO in adults (n=202) with ITP over…

ByRidhi RastogiSeptember 1, 2025

Womed Reports the US FDA’s Approval of Womed Leaf to Treat Asherman Syndrome

Novocure Reports MHLW’s Approval of Optune Lua for NSCLC

Zoetis’ Portela (Relfovetmab) Receives the CVMP’s Positive Opinion for Osteoarthritis Pain Relief in Cats

Sanofi’s Tzield Receives the NMPA’s Approval to Delay Progression of Type 1 Diabetes

Medison and Ipsen’s Bylvay Receives the Health Canada’s Approval to Treat Cholestatic Pruritus in Alagille Syndrome Patients

Takeda’s Vonvendi Receives the US FDA’s Approval for Adults and Children with Von Willebrand Disease

AbbVie’s Elahere (Mirvetuximab Soravtansine) Receives the Health Canada’s Approval to Treat Platinum-Resistant Ovarian Cancer

Henlius and Organon Receive the US FDA’s Approval for Bildyos & Bilprevda (Biosimilars, Prolia & Xgeva)

The NMPA Grants Conditional Approval to Boehringer Ingelheim’s Hernexeos for HER2-Mutant NSCLC

Sanofi’s Wayrilz (Rilzabrutinib) Receives the US FDA’s Approval for Immune Thrombocytopenia (ITP)

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