The US FDA Grants Fast Track Designation to Revalesio’s RNS60 for Treating Acute Ischemic Stroke

Shots: The US FDA has granted FTD to RNS60 (oxygen-enriched saline) for the treatment of acute ischemic stroke Designation was based on extensive preclinical data & P-II (RESCUE) trial, which showed reduced brain tissue loss, improved functional outcomes, & shorter hospital stays in pts treated within 24 hours of stroke onset Additionally, Revalesio is planning…

ByRidhi Rastogi13 hours ago

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Bioventus’ TalisMann and StimTrial Secure the US FDA 510(k) Clearances for Chronic Pain Management

Shots: The US FDA has granted 510(k) to both TalisMann & StimTrial for the management of chronic pain; limited US launch is planned in Q3’25, with broader rollout expected in early 2026 TalisMann integrates patented electric field conduction with a pulse generator to target deeper, larger nerves, & deliver long-term relief from chronic nerve pain,…

ByRidhi Rastogi4 days ago

NEWS

Novo Nordisk’s Alhemo Receives the US FDA’s Approval for Hemophilia A or B (HA/HB) Without Inhibitors

Shots: The US FDA has approved label expansion of Alhemo (concizumab-mtci) to prevent or reduce the frequency of bleeding episodes in pts (≥12yrs.) with HA/HB without inhibitors Approval was based on P-III (Explorer8) trial assessing Alhemo (n=42, 1mg/kg followed by 0.2mg/kg QD) vs no prophylaxis (n=21) in 156 males with HA/HB, where median duration of…

ByRidhi Rastogi4 days ago

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LENZ Therapeutics’ Vizz Receives the US FDA’s Approval to Treat Presbyopia

Shots: The US FDA has approved Vizz (1.44% aceclidine ophthalmic solution) for the treatment of presbyopia in adults; samples are expected in the US by Oct 2025, with full commercial launch by mid-Q4’25 Approval was based on the 3 P-III trials: CLARITY 1 & 2 evaluating Vizz (QD) in 466 pts for 42 days as…

ByRidhi Rastogi4 days ago

NEWS

AbbVie Reports the US FDA’s sNDA Submission of Venclexta + Acalabrutinib for Chronic Lymphocytic Leukemia

Shots: The US FDA has received sNDA of Venclexta (venetoclax) & acalabrutinib in previously untreated patients with chronic lymphocytic leukemia (CLL) sNDA was supported by AstraZeneca-sponsored P-III (AMPLIFY) trial assessing Venclexta + acalabrutinib ± Obinutuzumab vs chemoimmunotherapy in previously untreated CLL pts without del(17p) or TP53 mutation Trial showed that Venclexta + acalabrutinib a 35% reduction…

ByRidhi Rastogi5 days ago

NEWS

Cardiosense’s CardioTag Device Receives the US FDA’s 510(k) Clearance for Cardiac Function Assessment

Shots: The US FDA has granted 510(k) clearance to CardioTag device for assessing cardiac function Upon regulatory approval for the PCWP Analysis Software, the algorithm will be integrated with the CardioTag device for advanced heart failure management, following a multicenter study showing its PCWP value estimates matched implantable hemodynamic sensor accuracy in HFrEF pts; data was published…

ByRidhi Rastogi5 days ago

NEWS

Apellis Pharmaceuticals Reports the US FDA’s Approval of Empaveli for C3 Glomerulopathy and Primary IC-MPGN

Shots: The US FDA has approved Empaveli (pegcetacoplan) for C3 glomerulopathy (C3G) & primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) pts (≥12yrs.) Approval was based on P-III (VALIANT) trial assessing Empaveli (Q2W) vs PBO in C3G & primary IC-MPGN pts (≥12yrs., n=124) for 26wks. followed by 26wk. open-label period, where all pts received Empaveli Trial met…

ByRidhi RastogiJuly 30, 2025

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PTC Therapeutics Receives the US FDA’s Approval for Sephience to Treat Phenylketonuria

Shots: The US FDA has approved Sephience (sepiapterin) for the treatment of phenylketonuria (PKU) in pts of all ages, with broad labeling for hyperphenylalaninemia in adults & pediatric pts (≥1mos.) with sepiapterin-responsive PKU; review is ongoing in Japan & Brazil Approval was based on APHENITY study results & long-term extension data showing durable effects and…

ByRidhi RastogiJuly 29, 2025

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Sobi Reports the US FDA’s Approval of Doptelet (Avatrombopag) to Treat Pediatric Immune Thrombocytopenia

Shots: The US FDA has approved Doptelet to treat thrombocytopenia in pts (≥1yrs.) with persistent or chronic ITP who have not responded to prior treatments. Approval also incl. a new formulation, Doptelet Sprinkle (avatrombopag) oral granules, for children (1-6yrs.) Approval was based on P-III (AVA-PED-301) study assessing Doptelet in pediatric ITP pts, which showed that…

ByRidhi RastogiJuly 28, 2025

NEWS

Minnesota Medical Technologies Receives the US FDA’s 510(k) Clearance for StaySure to Manage Fecal Incontinence

Shots: Minnesota Medical Technologies has reported the US FDA’s 510(k) clearance to StaySure for the management of fecal incontinence (FI) A completed clinical trial demonstrated the device’s safety & efficacy, with a reduction in fecal incontinence frequency & improved QoL; full results are expected later in 2025 StaySure, marketed as Navina Insert in the EU, is…

ByRidhi RastogiJuly 25, 2025

The US FDA Grants Fast Track Designation to Revalesio’s RNS60 for Treating Acute Ischemic Stroke

Bioventus’ TalisMann and StimTrial Secure the US FDA 510(k) Clearances for Chronic Pain Management

Novo Nordisk’s Alhemo Receives the US FDA’s Approval for Hemophilia A or B (HA/HB) Without Inhibitors

LENZ Therapeutics’ Vizz Receives the US FDA’s Approval to Treat Presbyopia

AbbVie Reports the US FDA’s sNDA Submission of Venclexta + Acalabrutinib for Chronic Lymphocytic Leukemia

Cardiosense’s CardioTag Device Receives the US FDA’s 510(k) Clearance for Cardiac Function Assessment

Apellis Pharmaceuticals Reports the US FDA’s Approval of Empaveli for C3 Glomerulopathy and Primary IC-MPGN

PTC Therapeutics Receives the US FDA’s Approval for Sephience to Treat Phenylketonuria

Sobi Reports the US FDA’s Approval of Doptelet (Avatrombopag) to Treat Pediatric Immune Thrombocytopenia

Minnesota Medical Technologies Receives the US FDA’s 510(k) Clearance for StaySure to Manage Fecal Incontinence

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