Belite Bio Receives the US FDA Priority Review for Tinlarebant to Treat Stargardt Disease Type 1

Shots: The US FDA has accepted & granted Priority Review to the NDA for tinlarebant for the treatment of Stargardt Disease Type 1 (STGD1), with a PDUFA target date of Feb 12, 2027 NDA was supported by the P-III (DRAGON) trial assessing tinlarebant vs PBO in STGD1 pts, showing 35.7% reduction in atrophic retinal lesion growth…

ByRidhi RastogiAugust 12, 2026

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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 RastogiAugust 7, 2026

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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 RastogiAugust 7, 2026

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Bavarian Nordic Reports EC Approval of Imvanex Against Smallpox & Mpox for Children Aged 2 to Less than 12 Years

Shots: The EC has approved type II variation MAA for Imvanex (MVA-BN) smallpox & mpox vaccine, extending its use to include children aged 2 to less than 12yrs. Approval was based on P-II trial data involving 227 children (2 to <12yrs.) & 224 adults, which showed non-inferior immune responses & a similar safety profile in children…

ByRidhi RastogiAugust 7, 2026

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FDA Grants Accelerated Approval to Replimune’s Tudriqev + Opdivo for Unresectable Cutaneous Melanoma Progressed on Anti-PD-1 Based Regimen

Shots: FDA has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg or RP1) + nivolumab for adults with unresectable advanced cutaneous melanoma whose disease progressed on an anti-PD-1 antibody-based regimen P-II (IGNYTE) trial enrolled 140 pts, with 91 efficacy-evaluable pts having ≥1 non-injected lesion. Tudriqev + nivolumab achieved a 24.2% ORR & an mDoR of 14.1mos., with results…

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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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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Ractigen Therapeutics Reports IND Clearance of RAG-1C for Proliferative Vitreoretinopathy

Shots: The US FDA has granted IND clearance for RAG-1C for the prevention & treatment of Proliferative Vitreoretinopathy (PVR) The P-I trial will assess the safety, tolerability, PK, & preliminary efficacy of RAG-1C in patients undergoing surgery for retinal detachment who are at high risk of developing PVR RAG-1C is an intravitreal saRNA therapy using Ractigen’s…

ByRidhi RastogiAugust 3, 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

Belite Bio Receives the US FDA Priority Review for Tinlarebant to Treat Stargardt Disease Type 1

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

Bavarian Nordic Reports EC Approval of Imvanex Against Smallpox & Mpox for Children Aged 2 to Less than 12 Years

FDA Grants Accelerated Approval to Replimune’s Tudriqev + Opdivo for Unresectable Cutaneous Melanoma Progressed on Anti-PD-1 Based Regimen

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

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

Ractigen Therapeutics Reports IND Clearance of RAG-1C for Proliferative Vitreoretinopathy

Novartis Reports the US FDA Approval of Pluvicto for mHSPC

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