Silence Therapeutics Reports Topline P-II (SANRECO) Trial Results of Divesiran in Polycythemia Vera

Shots: Silence has reported topline P-II (SANRECO) trial results assessing divesiran (6mg/kg, SC, Q6W or Q12W) vs PBO in 48 phlebotomy-dependent patients with polycythemia vera (PV); P-III PV trial for Q12W dosing to initiate in H1’27 Trial met its 1EP, with significantly more PV pts responding to divesiran vs PBO (88% vs 19%). Response was…

ByRidhi Rastogi15 hours ago

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Innate Pharma Collaborates with Sobi to License Lacutamab in Cutaneous T-cell Lymphoma (CTCL)

Shots: Innate Pharma & Sobi have entered into a strategic partnership to initiate P-III (TELLOMAK-3) trial of lacutamab in CTCL, supporting a planned accelerated approval filing in Sézary syndrome TELLOMAK-3 is expected to support full approval filings in Sézary syndrome & mycosis fungoides. Sobi will gain exclusive global commercialization rights upon potential accelerated approval &…

ByRidhi Rastogi2 days ago

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Health Canada Approves Regeneron’s Libtayo for Adjuvant Treatment of High-Risk Cutaneous Squamous Cell Carcinoma

Shots: Health Canada has approved Libtayo (cemiplimab) for the adj. treatment of adults with CSCC who are at high risk for recurrence after surgery & radiation Approval was based on the P-III (C-POST) trial assessing adj. Libtayo (n=209) vs PBO (n=206) to treat high-risk CSCC pts (N=415) Trial showed a 68% reduction in disease recurrence…

ByRidhi Rastogi4 days ago

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US FDA Accepts sBLA for Merck’s Enflonsia to Expand RSV LRTD Prevention Indication

Shots: FDA has accepted the sBLA of Enflonsia to prevent RSV lower respiratory tract disease (LRTD) in children (<2yrs.) at increased risk for severe RSV disease through their second RSV season (PDUFA: Mar 22, 2027); application is also under EMA review Submissions were supported by P-III (SMART/MK-1654-007) trial assessing Enflonsia in infants & children over…

ByRidhi Rastogi5 days ago

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The US FDA Approves Moderna’s mFLUSIVA Against Seasonal Influenza for Adults Aged 50 or More

Shots: FDA approved mFLUSIVA against seasonal influenza for use in adults (≥50yrs); supply to select retailers to be available in coming wks. Regulatory review is ongoing in the EU, Canada & Australia, with flings in other countries planned during 2026 Approval in pts (50–64yrs.) was backed by a P-III trial (n=40,805; ≥50yrs.) assessing safety &…

ByRidhi RastogiAugust 6, 2026

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Takeda Reports US FDA Approval of Orzeyful (Oveporexton) for Narcolepsy Type 1

Shots: The US FDA has approved Orzeyful (oveporexton) for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults. DEA scheduling decision is expected within 90 days, after which it will be available through a specialty pharmacy Approval was based on extensive data, incl. P-III (FirstLight & RadiantLight) trial assessing Orzeyful (BID) in…

ByRidhi RastogiAugust 6, 2026

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Summit Therapeutics Initiates P-II/III (HARMONi-GU1) Trial of Ivonescimab + Enfortumab Vedotin in Bladder Cancer

Shots: Summit has initiated P-II/III (HARMONi-GU1) trial of ivonescimab + enfortumab vedotin (EV) against Keytruda + EV as first-line treatment of locally advanced or metastatic urothelial (bladder) cancer The global, multi-regional trial will enroll ~800 pts through P-III, with site activations beginning later this year. P-II will determine the recommended P-III dose of ivonescimab in…

ByRidhi RastogiAugust 5, 2026

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Natera Seeks PMDA Approval for Signatera CDx in MIBC

Shots: Natera has submitted an application to Japan's PMDA seeking approval of Signatera as a companion diagnostic (CDx) for muscle-invasive bladder cancer (MIBC) The submission expands the company's presence in Japan, where Signatera became the country's first PMDA-approved molecular residual disease (MRD) test for colorectal cancer in Jun 2026 Application is supported by data from…

ByRidhi RastogiAugust 5, 2026

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Allergan Aesthetics Reports the US FDA’s sBLA Acceptance of Botox Cosmetic for Masseter Muscle Prominence

Shots: The US FDA has accepted sBLA for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of marked to very marked MMP associated with masseter muscle activity in adults sBLA was supported by 2 P-III (M21-416 and M21-417) studies, both of which met their 1EPs & showed improvements in the severity of MMP vs…

ByRidhi RastogiAugust 5, 2026

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Nurix Therapeutics Enrolled First Patient in P-III (DAYBreak CLL-306) Trial of Bexobrutideg in R/R CLL/SLL

Shots: Nurix has enrolled the first patient in the global P-III (DAYBreak CLL-306) study assessing bexobrutideg in pts with r/r chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received a covalent BTK inhibitor The trial, conducted under the collaboration between Nurix and Roche, is expected to enroll ~620 pts, where they will be randomized…

ByRidhi RastogiAugust 4, 2026

Silence Therapeutics Reports Topline P-II (SANRECO) Trial Results of Divesiran in Polycythemia Vera

Innate Pharma Collaborates with Sobi to License Lacutamab in Cutaneous T-cell Lymphoma (CTCL)

Health Canada Approves Regeneron’s Libtayo for Adjuvant Treatment of High-Risk Cutaneous Squamous Cell Carcinoma

US FDA Accepts sBLA for Merck’s Enflonsia to Expand RSV LRTD Prevention Indication

The US FDA Approves Moderna’s mFLUSIVA Against Seasonal Influenza for Adults Aged 50 or More

Takeda Reports US FDA Approval of Orzeyful (Oveporexton) for Narcolepsy Type 1

Summit Therapeutics Initiates P-II/III (HARMONi-GU1) Trial of Ivonescimab + Enfortumab Vedotin in Bladder Cancer

Natera Seeks PMDA Approval for Signatera CDx in MIBC

Allergan Aesthetics Reports the US FDA’s sBLA Acceptance of Botox Cosmetic for Masseter Muscle Prominence

Nurix Therapeutics Enrolled First Patient in P-III (DAYBreak CLL-306) Trial of Bexobrutideg in R/R CLL/SLL

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