GSK Reports the US FDA’s Approval of Blujepa (Gepotidacin) to Treat Uncomplicated Urinary Tract Infections (uUTIs)

Shots: The US FDA has approved Blujepa to treat uUTIs in female adults (≥40kg) & adolescents (≥12yrs., ≥40kg) caused by E. coli, K. pneumoniae, C. freundii complex, S. saprophyticus & E. faecalis; commercially available in H2’25 Approval was based on P-III (EAGLE-2, n=1531; EAGLE-3, n=1605) studies assessing gepotidacin (1500mg, PO, BID for 5 days) vs nitrofurantoin (100mg, PO, BID for 5 days)…

ByDipanshu DixitMarch 26, 2025

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Sanofi Reports the US FDA’s Acceptance & Priority Review of Tolebrutinib for Non-Relapsing Secondary Progressive Multiple Sclerosis

Shots: The US FDA has accepted NDA & granted priority review to tolebrutinib for nrSPMS & slowing disability progression independent of relapse (PDUFA: Sep 28, 2025); MAA is under EMA review Submission was backed by P-III trials, incl. HERCULES for nrSPMS & GEMINI 1 & 2 for relapsing MS, along with clinical & preclinical data…

ByRidhi RastogiMarch 25, 2025

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Bayer Reports the US FDA’s sNDA Acceptance & Priority Review of Finerenone for Heart Failure (HF)

Shots: The US FDA has accepted sNDA & granted priority review to finerenone for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF), with approval expected in Q3’25. Awaits authorization in China, EU & Japan, with global applications planned Application was backed by P-III…

ByRidhi RastogiMarch 18, 2025

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Perfuze Secures the US FDA’s 510(k) Clearance for its Zipline Access Catheters

Shots: The US FDA has granted 510(k) clearance to Zipline Access Catheters to treat acute ischemic strokes Zipline improves delivery of a large (070) & superbore (088) aspiration catheter to enhance trackability & simplify neuro-interventional procedures for faster as well as more efficient stroke treatment. Zipline also optimizes clot removal & improves success rates…

ByRidhi RastogiMarch 17, 2025

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Beckman Coulter Receives the US FDA 510(k) Clearance For DxC 500i Clinical Analyzer

Shots: The US FDA granted 510(k) Clearance to the DxC 500i Clinical Analyzer, an integrated clinical chemistry and immunoassay analyzer capable of processing up to 800 clinical chemistry and 100 immunoassay tests per hour The DxC 500i analyzer leverages Beckman’s previous model DxC 500 AU technology within its clinical chemistry capabilities, including its Six…

ByRidhi RastogiMarch 11, 2025

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The US FDA Grants 510(k) Clearance to Zimmer Biomet’s Persona Revision SoluTion Femur

Shots: The US FDA has granted 510(k) clearance to Persona Revision SoluTion Femur as an alternative for knee implant in pts with metal sensitivities; commercially available in the US in Q3’25 SoluTion Femur, part of the Persona Revision Knee System, utilizes surface-hardening treatment for enhanced wear performance & provides surgeons with anatomic components, incl.…

ByRidhi RastogiMarch 10, 2025

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Celltrion’s Omlyclo (Biosimilar, Xolair) Secures the US FDA’s Approval

Shots: The US FDA has approved & granted interchangeability designation to Omlyclo, a biosimilar to Xolair (omalizumab) for the treatment of mod. to sev. persistent asthma, CRSwNP, IgE-mediated food allergy, & chronic spontaneous urticaria (CSU) Approval was based on multiple clinical evidence, incl. P-III trial assessing Omlyclo (150mg, Q4W) vs Xolair (300mg, Q4W) in…

ByDipanshu DixitMarch 10, 2025

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The EC Approves BMS’ Opdivo + Yervoy as 1L Treatment for Hepatocellular Carcinoma

Shots: The EC has approved Opdivo + Yervoy as 1L therapy to treat inoperable or advanced HCC adult pts in 30 EEA states; sBLA under the US FDA’s priority review (PDUFA: Apr 21, 2025) Approval was based on P-III (CheckMate-9DW) trial assessing Opdivo (1mg/kg, Q3W) + Yervoy (3mg/kg, Q3W), followed by Opdivo alone (480mg,…

ByRidhi RastogiMarch 10, 2025

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Neurotech Pharmaceuticals Reports the US FDA Approval for Encelto to treat Macular Telangiectasia Type 2

Shots: The US FDA has approved Encelto (revakinagene taroretcel-lwey) to treat macular telangiectasia type 2 (MacTel); commercially available in the US by Jun 2025 Approval was based on P-III trial data demonstrating reduced macular photoreceptor loss for ~24mos. post-implantation Encelto (intravitreal implant) utilizes an encapsulated cell therapy tech to continuously deliver ciliary neurotrophic…

ByRidhi RastogiMarch 7, 2025

NEWS

Tris Pharma Reports P-III Clinical Data of Cebranopadol to Treat Moderate-to-Severe Acute Pain

Shots: Tris has reported topline data from P-III (ALLEVIATE-2) trial in post-bunionectomy pts, plus additional data from P-III (ALLEVIATE-1) trial in post-abdominoplasty pts. Data from both trials, plus HAP studies will support the US FDA’s NDA filing in 2025 ALLEVIATE-2 evaluated cebranopadol (400µg QD, PO) vs oxycodone (10mg QID, PO) vs PBO, meeting its…

ByRidhi RastogiMarch 7, 2025

GSK Reports the US FDA’s Approval of Blujepa (Gepotidacin) to Treat Uncomplicated Urinary Tract Infections (uUTIs)

Sanofi Reports the US FDA’s Acceptance & Priority Review of Tolebrutinib for Non-Relapsing Secondary Progressive Multiple Sclerosis

Bayer Reports the US FDA’s sNDA Acceptance & Priority Review of Finerenone for Heart Failure (HF)

Perfuze Secures the US FDA’s 510(k) Clearance for its Zipline Access Catheters

Beckman Coulter Receives the US FDA 510(k) Clearance For DxC 500i Clinical Analyzer

The US FDA Grants 510(k) Clearance to Zimmer Biomet’s Persona Revision SoluTion Femur

Celltrion’s Omlyclo (Biosimilar, Xolair) Secures the US FDA’s Approval

The EC Approves BMS’ Opdivo + Yervoy as 1L Treatment for Hepatocellular Carcinoma

Neurotech Pharmaceuticals Reports the US FDA Approval for Encelto to treat Macular Telangiectasia Type 2

Tris Pharma Reports P-III Clinical Data of Cebranopadol to Treat Moderate-to-Severe Acute Pain

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