Ascletis Reports the US FDA’s IND Submission for ASC36 and ASC36_35 FDC to Treat Obesity

Shots: The US FDA has received IND applications for ASC36, a QM to Q3M peptide amylin receptor agonist, & ASC36_35 FDC, a QM injection co-formulation of ASC36 + ASC35, for the treatment of obesity In NHP studies, ASC36 SALD showed ~6-fold longer half-life than eloralintide, supporting QM to Q3M SC dosing, while ASC36_35 FDC SALD…

ByRidhi RastogiJuly 6, 2026

NEWS

PolarityBio Reports the US FDA BLA Submission of SkinTE for Wagner Grade 1 Diabetic Foot Ulcers

Shots: The US FDA has received the BLA of SkinTE for the treatment of Wagner Grade 1 diabetic foot ulcers (DFUs) BLA submission follows the P-III (COVER DFUS II) trial assessing SkinTE + SoC vs SoC alone in 120 pts with Wagner 1 DFU, which met its 1EP of complete wound closure SkinTE is a first-in-class autologous…

ByRidhi RastogiJuly 3, 2026

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Visby Medical Secures FDA Clearance for At-Home Flu & COVID-19 PCR Test

Shots: The US FDA has granted clearance to Flu and COVID-19 Test, an at-home PCR test capable of detecting multiple respiratory viruses, expanding its portfolio of over-the-counter molecular diagnostics The test delivers PCR-quality results in 30min. & detects COVID-19 and influenza A/B at home, enabling earlier diagnosis & timely treatment decisions, incl. access to antiviral…

ByRidhi RastogiJuly 3, 2026

NEWS

Samsung Bioepis and Harrow Relaunch Byooviz (Biosimilar, Lucentis) in the US

Shots: Samsung Bioepis, in partnership with Harrow, has relaunched Byooviz, a biosimilar to Lucentis (ranibizumab), in the US Byooviz was initially commercialized by Biogen beginning in Jun 2022, before Biogen returned the US commercial rights to Samsung Bioepis at the end of 2025 Approved by the FDA in 2021 as the first ophthalmology biosimilar, Byooviz…

ByRidhi RastogiJuly 1, 2026

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RefleXion Seeks FDA Clearance for Anchor Point Tumor Tracking

Shots: The US FDA has received a 510(k) premarket notification for Anchor Point Tracking, a tumor tracking technology designed for use with its new RefleXion X2 radiotherapy platform Filing is backed by extensive system validation & phantom testing, with additional data from academic investigators demonstrating improved target tracking, dose conformity, motion management, & organ-at-risk sparing…

ByRidhi RastogiJuly 1, 2026

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Orca Bio’s Tregzi Wins FDA Approval for Allogeneic Transplant in Adults with Hematological Malignancies

Shots: The US FDA has approved Tregzi (Orca-T) for use in a stem cell transplant to improve survival free of chronic graft versus host disease (GVHD) in adults with hematological malignancies Approval was backed by the P-III (Precision-T) trial assessing Orca-T + TAC vs conventional alloHSCT in pts (n=187) with acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, &…

ByRidhi RastogiJuly 1, 2026

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Roche’s Enspryng Receives the US FDA Priority Review for At-Home SC Treatment of Thyroid Eye Disease

Shots: The US FDA has accepted sBLA & granted priority review to Roche's Enspryng (satralizumab; SC) for the treatment of thyroid eye disease (TED), with a decision expected by Oct 15, 2026 sBLA was supported by P-III (SatraGO-1 & SatraGO-2) trials assessing Enspryng vs PBO in total of 258 adults with active, mod. to sev.…

ByRidhi RastogiJune 30, 2026

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Viridian Therapeutics Reports the US FDA Approval of Lumvoa (veligrotug-vvze) for Thyroid Eye Disease

Shots: The US FDA has approved Lumvoa (veligrotug-vvze) for the treatment of thyroid eye disease (TED), with immediate launch planned across the US. Also, SC elegrobart BLA filing for TED on track for Q1’27 Approval was granted under FDA Priority Review & supported by the P-III THRIVE (active TED) & THRIVE-2 (chronic TED) trials, which…

ByRidhi RastogiJune 29, 2026

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Ionis’ Tryngolza Receives the US FDA Approval for Patients with Severe Hypertriglyceridemia

Shots: The US FDA has approved Tryngolza (olezarsen; 50 or 80mg, QM) as an adjunct to diet to reduce triglycerides (TG) & the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG); commercially available in Jul 2026 Approval was based on the P-III (CORE: n=617 & CORE2: n=446) trials assessing Tryngolza (SC) vs PBO…

ByRidhi RastogiJune 26, 2026

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Merck and Gilead Report FDA Approval of Trodelvy + Keytruda for Previously Untreated PD-L1+ TNBC

Shots: The US FDA has approved Trodelvy + Keytruda/Keytruda Qlex for the 1L treatment of adults with inoperable, locally advanced, or metastatic TNBC expressing PD-L1 (CPS ≥ 10) Approval was based on the P-III (ASCENT-04/KEYNOTE-D19) trial assessing Trodelvy (10mg/kg, IV, Day 1 & 8 of each 21-day cycle) + Keytruda (200mg, IV, Day 1 of…

ByRidhi RastogiJune 25, 2026

Ascletis Reports the US FDA’s IND Submission for ASC36 and ASC36_35 FDC to Treat Obesity

PolarityBio Reports the US FDA BLA Submission of SkinTE for Wagner Grade 1 Diabetic Foot Ulcers

Visby Medical Secures FDA Clearance for At-Home Flu & COVID-19 PCR Test

Samsung Bioepis and Harrow Relaunch Byooviz (Biosimilar, Lucentis) in the US

RefleXion Seeks FDA Clearance for Anchor Point Tumor Tracking

Orca Bio’s Tregzi Wins FDA Approval for Allogeneic Transplant in Adults with Hematological Malignancies

Roche’s Enspryng Receives the US FDA Priority Review for At-Home SC Treatment of Thyroid Eye Disease

Viridian Therapeutics Reports the US FDA Approval of Lumvoa (veligrotug-vvze) for Thyroid Eye Disease

Ionis’ Tryngolza Receives the US FDA Approval for Patients with Severe Hypertriglyceridemia

Merck and Gilead Report FDA Approval of Trodelvy + Keytruda for Previously Untreated PD-L1+ TNBC

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