Johnson & Johnson’s Darzalex Faspro Secures the US FDA’s Approval for High-Risk Smouldering Multiple Myeloma (SMM)

Shots:FDA has approved Darzalex Faspro (daratumumab & hyaluronidase-fihj) for high‑risk SMM based on the P-III (AQUILA) study assessing Darzalex Faspro alone vs active monitoring in adults, which met its 1EP of improved PFS by 51%, with 63.1% vs 40.7% pts progression-free at a mFU of 65.2mos.Trial also showed an improved ORR (63.4% vs…

ByRidhi RastogiNovember 7, 2025

NEWS

Averoa Receives the MHRA’s Approval for Xoanacyl to Treat Chronic Kidney Disease (CKD)

Shots:The UK’s MHRA has approved Xoanacyl (ferric citrate complex) for the treatment of concomitant elevated serum phosphorus & iron deficiency in CKD adults via International Recognition Procedure (Route B), following EC’s approval in Jun 2025In Dec 2022, Averoa obtained an exclusive license from Akebia Therapeutics to develop & commercialize Xoanacyl in the EEA,…

ByRidhi RastogiNovember 6, 2025

NEWS

UCB Reports the US FDA’s Approval of Kygevvi (Doxecitine + Doxribtimine) for Thymidine Kinase 2 Deficiency (TK2d)

Shots:FDA has approved Kygevvi (2g/2g; PO) for adults & pediatric pts with TK2d whose symptom onset occurred ≤12yrs. of age. Kygevvi is expected to launch in the US by Q1’26, & is under EMA's review, with additional regulatory filings plannedApproval was backed by a P-II trial, 2 retrospective chart review studies, & an…

ByRidhi RastogiNovember 4, 2025

NEWS

Daiichi Sankyo Reports the Health Canada’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

Shots:Health Canada has approved Enhertu monotx. for adult with inoperable HR+, HER2-low/ultralow MBC who have received ≥1 endocrine therapy (ET) & are ineligible for ET as the next line of therapyApproval was based on the P-III (DESTINY-Breast06) trial (N=866) assessing Enhertu (5.4mg/kg) vs CT (capecitabine/paclitaxel/nab-paclitaxel) in HR+, HER2-low (n=713) & ultralow (n=152) ptsTrial showed improved PFS…

ByRidhi RastogiOctober 31, 2025

NEWS

Merck Receives EC’s Approval for Perioperative Keytruda for Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

Shots:The EC has approved neoadj. Keytruda followed by adj. Keytruda + SoC radiotherapy (RT) ± cisplatin & then as a single agent to treat operable LA-HNSCC tumors expressing PD-L1 (CPS ≥1) across all 30 EEA statesApproval was based on P-III (KEYNOTE-689) trial assessing neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by adj. Keytruda (15…

ByRidhi RastogiOctober 30, 2025

NEWS

AstraZeneca Reports the EC’s Approval of Koselugo (Selumetinib) for Treating Neurofibromatosis Type 1

Shots:The EC has approved Koselugo for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adults with neurofibromatosis type 1 (NF1)Approval was based on the P-III (KOMET) study assessing Koselugo (PO) vs PBO in 145 adults with NF1 & symptomatic, inoperable PNs across 13 countries incl. North America, South America, Europe, Asia &…

ByRidhi RastogiOctober 28, 2025

NEWS

Syndax Pharmaceuticals’ Revuforj (Revumenib) Receives the US FDA’s Approval for NPM1-Mutated R/R Acute Myeloid Leukemia

Shots:The US FDA has approved label expansion of Revuforj to treat pts (≥1yrs.) with nucleophosmin 1 (NPM1)-mutated r/r acute myeloid leukemia (AML) who have no satisfactory alternative treatment optionsApproval was supported by P-II results from the P-I/II (AUGMENT-101) trial, which showed a 23% CR + CRh rate (15/65), median response time of 2.8mos.,…

ByRidhi RastogiOctober 28, 2025

NEWS

Eli Lilly’s Omvoh (mirikizumab-mrkz) Receives the US FDA’s Approval for Ulcerative Colitis

Shots:The US FDA has approved Omvoh (200mg/2mL, SC, QM) as a maintenance treatment of adults with mod. to sev. active ulcerative colitis; PFS & prefilled pen to be available in early 2026Approval was based on P-I trial assessing Omvoh (200mg/2mL, SC) single injection vs 2 100mg/1mL injections in participants, which showed bioequivalence between the…

ByDipanshu DixitOctober 28, 2025

NEWS

Bayer Reports the US FDA’s Approval of Lynkuet (Elinzanetant) to Treat Vasomotor Symptoms

Shots:The US FDA has approved Lynkuet for the treatment of mod. to sev. vasomotor symptoms due to menopause based on P-III (OASIS-1, 2, & 3) trials, with commercial availability expected at the start of Nov 2025; MAA is under the EMA’s review Efficacy was evaluated in OASIS-1 & 2 trials assessing Lynkuet vs PBO…

ByRidhi RastogiOctober 27, 2025

NEWS

Boehringer Ingelheim Reports the NMPA’s Approval of Jascayd (Nerandomilast) for Idiopathic Pulmonary Fibrosis

Shots:The NMPA has approved Jascayd (nerandomilast) for the treatment of adults with idiopathic pulmonary fibrosis (IPF); regulatory review is ongoing in Japan & the EU, with further filings plannedApproval was based on P-III (FIBRONEER-IPF) assessing Jascayd (18 or 9mg, PO, BID) vs PBO in IPF pts, which met its 1EP of reduced FVC decline at…

ByRidhi RastogiOctober 24, 2025

Johnson & Johnson’s Darzalex Faspro Secures the US FDA’s Approval for High-Risk Smouldering Multiple Myeloma (SMM)

Averoa Receives the MHRA’s Approval for Xoanacyl to Treat Chronic Kidney Disease (CKD)

UCB Reports the US FDA’s Approval of Kygevvi (Doxecitine + Doxribtimine) for Thymidine Kinase 2 Deficiency (TK2d)

Daiichi Sankyo Reports the Health Canada’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

Merck Receives EC’s Approval for Perioperative Keytruda for Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

AstraZeneca Reports the EC’s Approval of Koselugo (Selumetinib) for Treating Neurofibromatosis Type 1

Syndax Pharmaceuticals’ Revuforj (Revumenib) Receives the US FDA’s Approval for NPM1-Mutated R/R Acute Myeloid Leukemia

Eli Lilly’s Omvoh (mirikizumab-mrkz) Receives the US FDA’s Approval for Ulcerative Colitis

Bayer Reports the US FDA’s Approval of Lynkuet (Elinzanetant) to Treat Vasomotor Symptoms

Boehringer Ingelheim Reports the NMPA’s Approval of Jascayd (Nerandomilast) for Idiopathic Pulmonary Fibrosis

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