Pfizer and Valneva Report EMA’s MAA Validation for PF-07307405 Against Lyme Disease

Shots: The EMA has validated the MAA for PF-07307405, a 6-valent outer surface protein A (OspA)-based Lyme disease vaccine candidate and will begin its assessment of the application developed in collaboration between Pfizer & Valneva The application is supported by >70% efficacy in the P-III (VALOR) trial, which evaluated PF-07307405 in individuals aged ≥5 years.…

ByRidhi Rastogi5 minutes ago

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BMS Reports the US FDA Accelerated Approval for Zenbexus (Iberdomide) Combination in R/R Multiple Myeloma (MM)

Shots: FDA has granted accelerated approval to Zenbexus (iberdomide) + daratumumab & hyaluronidase-fihj + dexamethasone (ZDd) for the treatment of pts with MM who received ≥1L of prior therapy incl. a proteasome inhibitor & an immunomodulatory agent Approval was supported by the P-III (EXCALIBER-RRMM) trial assessing ZDd (n=207) vs daratumumab + bortezomib + dexamethasone (DVd;…

ByRidhi Rastogi2 hours ago

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Summit and Akeso Reports NMPA Approval for Ivonescimab + CT for 1L Squamous NSCLC

Shots: Chinese NMPA has approved ivonescimab + CT for the 1L treatment of pts with advanced squamous NSCLC (sqNSCLC), based on the global P-III (HARMONi-6) trial The trial, sponsored by Akeso, assessed ivonescimab + CT vs Tevimbra + CT to treat Chinese pts with 1L sqNSCLC irrespective of PD-L1 expression, showing improved OS & PFS;…

ByRidhi Rastogi1 day ago

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Rhythm Pharmaceuticals’ Imcivree Receives Expanded UK Authorization for Hypothalamic Obesity

Shots: The MHRA has expanded market authorization for Imcivree (setmelanotide) to incl. the treatment of obesity & control of hunger in pts (≥4yrs.) with acquired hypothalamic obesity due to hypothalamic injury or impairment Approval was backed by the global P-II/III (TRANSCEND) trial assessing Imcivree vs PBO in 120 pts with acquired HO, meeting its 1EP with…

ByRidhi Rastogi2 days ago

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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 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 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

Pfizer and Valneva Report EMA’s MAA Validation for PF-07307405 Against Lyme Disease

BMS Reports the US FDA Accelerated Approval for Zenbexus (Iberdomide) Combination in R/R Multiple Myeloma (MM)

Summit and Akeso Reports NMPA Approval for Ivonescimab + CT for 1L Squamous NSCLC

Rhythm Pharmaceuticals’ Imcivree Receives Expanded UK Authorization for Hypothalamic Obesity

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

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