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 Rastogi2 days ago

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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 Rastogi2 days ago

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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 Rastogi2 days ago

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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 Rastogi3 days ago

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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 Rastogi4 days ago

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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

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Ionis Inks ex-US Deal with Recordati for Zilganersen in Alexander Disease

Shots: Ionis has granted Recordati exclusive rights to develop & commercialize zilganersen for Alexander disease outside the US, while Ionis retains US commercialization rights & will continue to lead global development Ionis will receive $30M upfront & additional milestone payments, with tiered royalties of up to the mid-20% range on annual net sales. Recordati will…

ByRidhi RastogiJune 25, 2026

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Pfizer’s Ibrance Combination Receives FDA Approval as a Maintenance Therapy for HR+, HER2+ Metastatic Breast Cancer

Shots: The US FDA has approved Pfizer's Ibrance (palbociclib) + trastuzumab ± pertuzumab, & endocrine therapy for the maintenance treatment of adults with HR+, HER2+ locally advanced or metastatic breast cancer following induction treatment Approval was based on the AFT-sponsored P-III (PATINA) trial, where pts receiving a median of 6 cycles of induction treatment were…

ByRidhi RastogiJune 25, 2026

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The US FDA Expands Merck’s Capvaxive Use to Children and Adolescents Aged 2-17 at Increased Risk for Pneumococcal Disease

Shots: The US FDA has expanded the indication for Capvaxive to incl. pts aged 2–17yrs. with certain chronic medical conditions who have completed a primary pediatric pneumococcal vaccination series & remain at increased risk of pneumococcal disease Approval was supported by P-III (STRIDE-13) trial data, which compared Capvaxive with PPSV23 in the above-mentioned pts Capvaxive…

ByRidhi RastogiJune 19, 2026

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

Ionis Inks ex-US Deal with Recordati for Zilganersen in Alexander Disease

Pfizer’s Ibrance Combination Receives FDA Approval as a Maintenance Therapy for HR+, HER2+ Metastatic Breast Cancer

The US FDA Expands Merck’s Capvaxive Use to Children and Adolescents Aged 2-17 at Increased Risk for Pneumococcal Disease

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