Astellas and Pfizer Report the US FDA Approval of Perioperative Padcev + Keytruda for Muscle-Invasive Bladder Cancer (MIBC)

Shots: FDA has approved Padcev (enfortumab vedotin-ejfv) + Keytruda or Keytruda Qlex for neoadj. & adj. treatment for cisplatin-ineligible pts with MIBC, before the PDUFA action date (Apr 07, 2026) Approval was based on the P-III (KEYNOTE-905/EV-303) trial, which randomized cisplatin-ineligible MIBC pts to Arm A (3 cycles of Keytruda + surgery with 14 subsequent cycles), Arm B…

ByRidhi RastogiNovember 24, 2025

NEWS

AstraZeneca Reports the US FDA Approval of Koselugo (Selumetinib) for Treating Neurofibromatosis Type 1

Shots: The US FDA 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 RastogiNovember 20, 2025

NEWS

Merck’s Keytruda SC Receives the EC Approval for Subcutaneous Use Across 33 Solid Tumor Indications for Keytruda

Shots: The EC has approved Keytruda SC (pembrolizumab & berahyaluronidase alfa-pmph) for SC dosing in adults across all 33 Keytruda indications in all 30 EEA states, with availability subject to multiple factors, incl. national reimbursement processes Approval was based on P-III (3475A-D77) trial assessing Keytruda SC (790mg/9600 units, Q6W; n=251) vs IV Keytruda (400mg, Q6W;…

ByRidhi RastogiNovember 20, 2025

NEWS

Bayer Reports the EC Approval of Lynkuet (Elinzanetant) to Treat Vasomotor Symptoms

Shots: The EC has approved Lynkuet for the treatment of mod. to sev. vasomotor symptoms due to menopause or caused by adj. endocrine therapy related to breast cancer; regulatory filings are ongoing in other regions Approval was based on P-III (OASIS) program assessing Lynkuet (120mg, QD, PO), which consists of OASIS-1 (n=396), OASIS-2 (n=400) &…

ByRidhi RastogiNovember 20, 2025

NEWS

Henlius and Organon Receive the US FDA’s Approval for Poherdy (Biosimilar, Perjeta)

Shots: The US FDA has approved Poherdy (420mg/14mL, IV), an interchangeable biosimilar version of Perjeta (pertuzumab) for all indications of the reference product Approval was based on extensive clinical data, incl. analytical, PK & clinical studies, which showed similarity & interchangeability in terms of safety, purity, & potency between Poherdy & reference pertuzumab In 2022,…

ByRidhi RastogiNovember 19, 2025

NEWS

Insmed Reports the EC’s Approval of Brinsupri (Brensocatib) for Non-Cystic Fibrosis Bronchiectasis (NCFB)

Shots: The EC has approved Brinsupri (25mg) for treating NCFB pts (≥12yrs.), with ≥2 exacerbations in the prior 12mos. under EMA'saccelerated assessment pathway; Application is under PMDA & MHRA review, & Insmed is planning to work with EU authorities to enable patient access starting in early 2026 Approval was based on extensive clinical data, incl. P-III (ASPEN)…

ByRidhi RastogiNovember 19, 2025

NEWS

Arrowhead Pharmaceuticals Receives the US FDA’s Approval for Redemplo (Plozasiran) to Treat Familial Chylomicronemia Syndrome (FCS)

Shots: The US FDA has approved Redemplo as an adjunct to diet to reduce triglycerides (TGs) in adults with FCS; US availability is expected by year-end Approval was based on the P-III (PALISADE) trial assessing Redemplo (25mg & 50mg, SC, Q3M) vs PBO in 75 adults with genetically confirmed/clinically diagnosed FCS. Pts could join a…

ByRidhi RastogiNovember 19, 2025

NEWS

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

Shots: The EC has approved Omlyclo, a biosimilar version of Xolair (omalizumab), in PFS presentation (300 mg/2ml) for the treatment of pts with allergic asthma, chronic spontaneous urticaria (CSU) & chronic rhinosinusitis with nasal polyps (CRSwNP) Omlyclo previously received the EC approval in May 2024 for PFS injections at 75mg/0.5mL & 150mg/1mL Omalizumab is a…

ByRidhi RastogiNovember 18, 2025

NEWS

Kura Oncology and Kyowa Kirin Report the US FDA’s Approval Komzifti (Ziftomenib) for NPM1-Mutated Acute Myeloid Leukemia (AML)

Shots: The US FDA has granted full approval to Komzifti (QD, PO) to treat adults with r/r AML with NPM1 mutation who have no satisfactory alternative treatment options before the PDUFA date of Nov 30, 2025 Approval was backed by P-I/II (KOMET-001) trial in 112 r/r NPM1-mutant AML pts, showing 21.4% CR + CRh with a median…

ByRidhi RastogiNovember 14, 2025

NEWS

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

Astellas and Pfizer Report the US FDA Approval of Perioperative Padcev + Keytruda for Muscle-Invasive Bladder Cancer (MIBC)

AstraZeneca Reports the US FDA Approval of Koselugo (Selumetinib) for Treating Neurofibromatosis Type 1

Merck’s Keytruda SC Receives the EC Approval for Subcutaneous Use Across 33 Solid Tumor Indications for Keytruda

Bayer Reports the EC Approval of Lynkuet (Elinzanetant) to Treat Vasomotor Symptoms

Henlius and Organon Receive the US FDA’s Approval for Poherdy (Biosimilar, Perjeta)

Insmed Reports the EC’s Approval of Brinsupri (Brensocatib) for Non-Cystic Fibrosis Bronchiectasis (NCFB)

Arrowhead Pharmaceuticals Receives the US FDA’s Approval for Redemplo (Plozasiran) to Treat Familial Chylomicronemia Syndrome (FCS)

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

Kura Oncology and Kyowa Kirin Report the US FDA’s Approval Komzifti (Ziftomenib) for NPM1-Mutated Acute Myeloid Leukemia (AML)

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

Contact US

FOLLOW US