Pharming Reports the US FDA’s sNDA Acceptance and Priority Review to Leniolisib for Activated Phosphoinositide 3-Kinase Delta Syndrome

Shots: The US FDA has accepted sNDA & granted priority review to leniolisib for the treatment of children (4-11yrs.) with activated phosphoinositide 3-kinase delta (APKD) syndrome (PDUFA: Jan 31, 2026); regulatory review is ongoing in the EEA, Japan & Canada sNDA was supported by a P-III trial in APKD pediatric pts (4-11yrs.), which showed reduced…

ByRidhi RastogiOctober 1, 2025

NEWS

Daiichi Sankyo and AstraZeneca Receive the US FDA’s Priority Review for Enhertu + Perjeta to Treat HER2+ Breast Cancer

Shots: The US FDA has accepted sBLA & granted priority review to Enhertu + Perjeta for the 1L treatment of adults with unresectable or metastatic HER2+ breast cancer, which will be reviewed under RTOR pathway (PDUFA: Jan 23, 2026) sBLA was supported by P-III (DESTINY-Breast09) trial data on Enhertu (5.4mg/kg) ± Perjeta vs taxane, trastuzumab & Perjeta…

ByRidhi RastogiSeptember 24, 2025

NEWS

Corcept Therapeutics Reports the US FDA’s NDA Acceptance of Relacorilant to Treat Platinum-Resistant Ovarian Cancer

Shots: The US FDA has accepted NDA of relacorilant for the treatment of Pt-resistant ovarian cancer (PDUFA: Jul 11, 2026) NDA was supported by P-III (ROSELLA) & P-II trials, where relacorilant + nab-paclitaxel demonstrated improved PFS & OS compared to nab-paclitaxel monotx., with no need for biomarker selection & favorable safety Additionally, relacorilant (GR antagonist)…

ByRidhi RastogiSeptember 11, 2025

NEWS

Sobi Reports the US FDA’s BLA Acceptance of Nanoecapsulated Sirolimus + Pegadricase for Uncontrolled Gout

Shots: The US FDA has accepted the BLA of Nanoecapsulated Sirolimus + Pegadricase (NASP; Q4W) for the treatment of uncontrolled gout (PDUFA: Jun 27, 2026) BLA was supported by P-III (DISSOLVE I & II) trials evaluating 2 NASP doses vs PBO in adults with uncontrolled gout, which met its 1EP of sustained decrease in serum…

ByRidhi RastogiSeptember 10, 2025

NEWS

Shionogi Reports the US FDA’s Acceptance of Ensitrelvir Post-Exposure COVID-19 Prevention

Shots: The US FDA has accepted NDA of ensitrelvir fumaric acid for the prevention of COVID-19 following exposure to an infected individual (PDUFA: Jun 16, 2026); regulatory review is ongoing in Taiwan, Japan (for both PEP & paediatric pts), & the EU NDA was supported by global P-III (SCORPIO-PEP) trial assessing ensitrelvir vs PBO as post-exposure…

ByRidhi RastogiSeptember 3, 2025

NEWS

GSK Reports the US FDA’s sNDA Acceptance and Priority Review of Blujepa for Uncomplicated Urogenital Gonorrhoea

Shots: The US FDA has accepted sNDA & granted priority review to Blujepa (gepotidacin) for the treatment of pts (≥12yrs.; ≥45kg) with uncomplicated urogenital gonorrhoea (PDUFA: Dec 11, 2025); regulatory review is ongoing in the UK & Australia sNDA was backed by P-III (EAGLE-1) trial assessing Blujepa (2 doses × 3000mg; PO) vs ceftriaxone (500mg; IM)…

ByRidhi RastogiAugust 11, 2025

NEWS

Genmab Reports P-III (EPCORE FL-1) Trial Data on Epcoritamab for R/R Follicular Lymphoma

Shots: Genmab has reported P-III (EPCORE FL-1) trial data assessing epcoritamab (SC) + rituximab & lenalidomide (R2) vs R2 alone for the treatment of adult patients with r/r follicular lymphoma The trial met dual primary endpoints with improved ORR and PFS, reducing risk of progression or death by 79%; interim data will be submitted to…

ByRidhi RastogiAugust 8, 2025

NEWS

Taiho Oncology (Part of Taiho Pharmaceutical) Reports the US FDA’s sNDA Acceptance of Inqovi + Venetoclax for Newly Diagnosed AML

Shots: The US FDA has accepted sNDA of Inqovi (decitabine & cedazuridine) + venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) pts, ineligible for intensive induction CT (PDUFA: Feb 25, 2026) sNDA was backed by P-IIb (ASCERTAIN-V) trial in 101 adults with newly diagnosed AML ineligible for intensive induction CT, where pts…

ByRidhi RastogiJuly 10, 2025

NEWS

Denali Therapeutics Reports the US FDA’s BLA Acceptance and Priority Review of Tividenofusp Alfa for Hunter Syndrome

Shots: The US FDA has accepted BLA & granted priority review to tividenofusp alfa for the treatment of Hunter syndrome (MPS II), with PDUFA target action date of Jan 5, 2026 BLA was supported by a P-I/II trial of tividenofusp alfa in 47 MPS II pts, as Denali prepares for its US commercial launch. It…

ByRidhi RastogiJuly 8, 2025

NEWS

Omeros Submits MAA to the EMA for Narsoplimab (OMS721) to Treat TA-TMA

S Shots: Omeros submitted an MAA to the EMA for narsoplimab to treat TA-TMA, with data demonstrating a 61% response rate and a 3x improvement in OS vs matched external controls; over 130 pts treated under expanded access data were also included EMA granted Narsoplimab ODD status, and CHMP review will start mid-July under centralized…

ByPrince GiriJune 30, 2025

Pharming Reports the US FDA’s sNDA Acceptance and Priority Review to Leniolisib for Activated Phosphoinositide 3-Kinase Delta Syndrome

Daiichi Sankyo and AstraZeneca Receive the US FDA’s Priority Review for Enhertu + Perjeta to Treat HER2+ Breast Cancer

Corcept Therapeutics Reports the US FDA’s NDA Acceptance of Relacorilant to Treat Platinum-Resistant Ovarian Cancer

Sobi Reports the US FDA’s BLA Acceptance of Nanoecapsulated Sirolimus + Pegadricase for Uncontrolled Gout

Shionogi Reports the US FDA’s Acceptance of Ensitrelvir Post-Exposure COVID-19 Prevention

GSK Reports the US FDA’s sNDA Acceptance and Priority Review of Blujepa for Uncomplicated Urogenital Gonorrhoea

Genmab Reports P-III (EPCORE FL-1) Trial Data on Epcoritamab for R/R Follicular Lymphoma

Taiho Oncology (Part of Taiho Pharmaceutical) Reports the US FDA’s sNDA Acceptance of Inqovi + Venetoclax for Newly Diagnosed AML

Denali Therapeutics Reports the US FDA’s BLA Acceptance and Priority Review of Tividenofusp Alfa for Hunter Syndrome

Omeros Submits MAA to the EMA for Narsoplimab (OMS721) to Treat TA-TMA

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