Novo Nordisk Reports the US FDA’s BLA Submission of Mim8 (Denecimig) for Haemophilia A with or without Inhibitors

Shots: The US FDA has accepted the BLA for Mim8 (denecimig; pre-filled, single-use pen) as routine prophylaxis to prevent or reduce bleeding episodes in adult & pediatric pts with hemophilia A (congenital FVIII deficiency), with or without inhibitors BLA was supported by FRONTIER2 trial assessing Mim8 (QW/QM) in pts (≥12yrs), FRONTIER3 trial assessing it in…

ByRidhi RastogiSeptember 30, 2025

NEWS

Gedeon Richter and Hikma Pharmaceuticals Receive the US FDA’s Approval for Enoby and Xtrenbo (Biosimilar, Prolia & Xgeva)

Shots: The US FDA has approved Enoby (RGB-14-P) & Xtrenbo (RGB-14-X), biosimilar versions of Prolia & Xgeva (denosumab) for the treatment of bone & skeletal disorders Approval was based on extensive clinical data submitted by Hikma, incl. analytical, non-clinical & clinical studies, which showed comparable quality, efficacy, safety & immunogenicity of Enoby & Xtrenbo to reference…

ByRidhi RastogiSeptember 29, 2025

NEWS

Amneal Pharmaceuticals Reports the US FDA’s BLA Filing for Biosimilar Candidate to Xolair (Omalizumab)

Shots: The US FDA has received a BLA for a biosimilar candidate to Novartis’ Xolair (omalizumab), developed by Kashiv BioSciences Additionally, Amneal expects to incur a $22.5M R&D milestone charge in Q3’25 instead of Q4 due to the earlier BLA filing & holds exclusive US commercialization rights for the product pending regulatory approval Xolair is…

ByRidhi RastogiSeptember 29, 2025

NEWS

ClearNote Health Receives UKCA Marking for its Avantect Multi-Cancer & Ovarian Cancer Detection Tests

Shots: ClearNote Health has received the UKCA certification for its Avantect Multi-Cancer & Ovarian Cancer tests to detect multiple cancers & support early diagnosis of ovarian cancer, respectively The Multi-Cancer Detection Test screens multiple cancers from a simple blood sample using 5-hydroxymethylcytosine & genomic biomarkers in cell-free DNA, & was selected for the NCI-funded Vanguard…

ByRidhi RastogiSeptember 25, 2025

NEWS

Hansa Biopharma Reports Topline P-III (ConfIdeS) Trial Data of Imlifidase in Kidney Transplantation

Shots: Hansa Biopharma has reported topline P-III (ConfIdeS) trial data assessing imlifidase vs control for 12mos. in 64 kidney transplant pts (cPRA ≥99.9%) across 25 US sites Trial met its 1EP of improved kidney function at 12mos. per mean eGFR, with pts achieving eGFR of 51.5 mL/min/1.73m2 vs 19.3 mL/min/1.73m2, plus reached statistical significance in…

ByRidhi RastogiSeptember 25, 2025

NEWS

Intellia Therapeutics Completes Enrollment in the P-III (HAELO) Study of Lonvoguran Ziclumeran (lonvo-z) in Hereditary Angioedema (HAE) Patients

Shots: Intellia Therapeutics completed enrollment in the global P-III (HAELO) study evaluating lonvo-z for treating HAE, finishing within 9mos. since the first patient was dosed in Jan 2025, with nearly half of the participants enrolled from the US The study P-III (HAELO) study will evaluate the efficacy and safety of lonvo-z in ≥60 adults and…

ByPrince GiriSeptember 19, 2025

NEWS

Ocugen Joins Forces with Kwangdong Pharmaceutical for OCU400 to Treat Retinitis Pigmentosa

Shots: Ocugen has entered into a licensing agreement with Kwangdong Pharmaceutical for OCU400 to treat retinitis pigmentosa As per the deal, Kwangdong will receive exclusive Korean rights to OCU400 in exchange for $7.5M in upfront & near-term milestones, $1.5M per $15M in sales, reaching ≥$180M in sales milestones, plus 25% royalties on net sales, while…

ByRidhi RastogiSeptember 15, 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

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

Novo Nordisk Reports the US FDA’s BLA Submission of Mim8 (Denecimig) for Haemophilia A with or without Inhibitors

Gedeon Richter and Hikma Pharmaceuticals Receive the US FDA’s Approval for Enoby and Xtrenbo (Biosimilar, Prolia & Xgeva)

Amneal Pharmaceuticals Reports the US FDA’s BLA Filing for Biosimilar Candidate to Xolair (Omalizumab)

ClearNote Health Receives UKCA Marking for its Avantect Multi-Cancer & Ovarian Cancer Detection Tests

Hansa Biopharma Reports Topline P-III (ConfIdeS) Trial Data of Imlifidase in Kidney Transplantation

Intellia Therapeutics Completes Enrollment in the P-III (HAELO) Study of Lonvoguran Ziclumeran (lonvo-z) in Hereditary Angioedema (HAE) Patients

Ocugen Joins Forces with Kwangdong Pharmaceutical for OCU400 to Treat Retinitis Pigmentosa

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

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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