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 RastogiAugust 7, 2026

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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

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Biocon Launches Yesafili (Biosimilar, Eylea) in the US

Shots: Biocon has reported the commercial launch of Yesafili, a biosimilar version of Eylea 2mg (aflibercept), in the US, which was previously approved & granted interchangeable designation In the P-III (INSIGHT) study in Diabetic Macular Edema (DME), Yesafili showed no clinically meaningful differences from Eylea in PK, safety, efficacy, or immunogenicity Yesafili is a VEGF inhibitor…

ByRidhi RastogiAugust 4, 2026

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Novartis Reports the US FDA Approval of Pluvicto for mHSPC

Shots: The US FDA has approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) with an androgen receptor pathway inhibitor (ARPI) for pts with PSMA+ metastatic androgen pathway modulation-naive/sensitive (mAPMN/S) prostate cancer Approval was based on the P-III (PSMAddition) trial, which showed Pluvicto + ARPI & ADT reduced the risk of progression or death by 28% vs SoC…

ByRidhi RastogiAugust 3, 2026

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Nippon Shinyaku Exercises US Option for AB2 Bio’s Tadekinig Alfa

Shots: Nippon has exercised its exclusive US commercialization option for tadekinig alfa in Primary Monogenic IL-18-Driven Hyperinflammatory Syndrome with NLRC4 & XIAP mutations, with AB2 Bio retaining US rights to all other indications & all rights outside the US AB2 Bio received a $6M option fee in 2025 & will now receive a $30M option…

ByRidhi RastogiJuly 30, 2026

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

Biocon Launches Yesafili (Biosimilar, Eylea) in the US

Novartis Reports the US FDA Approval of Pluvicto for mHSPC

Nippon Shinyaku Exercises US Option for AB2 Bio’s Tadekinig Alfa

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