NEWS

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 &…

August 10, 2026

Almirall Partners with CrystalO to Advance Novel Small Molecules in Medical Dermatology

Shots: Almirall & CrystalO have partnered to advance drug discovery research in medical dermatology, leveraging CrystalO's scientific expertise in ion channels with Almirall's experience in medical dermatology R&D As per the deal, CrystalO will use its AI & structure-based drug discovery platform for compound discovery, optimization, IND-enabling studies, & early clinical development through PoC. Almirall…

August 10, 2026

Elanco’s CLiK Extra Secures US FDA EUA for New World Screwworm (NWS) Prevention

Shots: FDA has granted Emergency Use Authorization for CLiK Extra (dicyclanil topical suspension) wound spray to prevent NWS infestations in livestock & select captive and wild animal species The spray can be applied around wounds, including those caused by birth or surgery, in sheep, cattle, goats, swine, camelids and several cervid and bison species. It…

August 10, 2026

Innovent and Daiichi Sankyo Partner to Commercialize Vanflyta in China

Shots: Innovent Biologics has entered into an exclusive agreement with Daiichi Sankyo to commercialize Vanflyta (quizartinib) in China As per the deal, Daiichi Sankyo will handle the development, manufacturing & supply of Vanflyta while Innovent will hold sole commercialization rights for Vanflyta in China Vanflyta was approved in China in Jun’26 for newly diagnosed FLT3-ITD-positive AML in…

August 10, 2026

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…

August 7, 2026

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…

August 7, 2026

Co-Diagnostics Submits FDA 510(k) and CLIA Waiver Applications for Point-of-Care PCR Flu A/B & RSV Test

Shots: Co-Diagnostics submitted a Dual FDA 510(k) premarket notification with a concurrent CLIA Waiver application for its Co-Dx PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro platform Submission was backed by clinical & analytical performance studies, incl. study of over 1,400 symptomatic pts across 9 US sites, & 27…

August 7, 2026

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…

August 7, 2026

Ono and Mediar Partner to Develop Antibody Therapies for Fibro-Inflammatory Diseases

Shots: Ono has entered into a drug discovery partnership & option agreement with Mediar Therapeutics to develop novel antibody therapeutics for fibro-inflammatory diseases As per the deal, Mediar will conduct research using its fibrosis-focused research platform, while Ono will gain exclusive worldwide option rights to select candidates for development, manufacturing, & commercialization The partnership will…

August 7, 2026

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…

August 7, 2026

NEWS

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

Almirall Partners with CrystalO to Advance Novel Small Molecules in Medical Dermatology

Elanco’s CLiK Extra Secures US FDA EUA for New World Screwworm (NWS) Prevention

Innovent and Daiichi Sankyo Partner to Commercialize Vanflyta in China

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

Co-Diagnostics Submits FDA 510(k) and CLIA Waiver Applications for Point-of-Care PCR Flu A/B & RSV Test

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

Ono and Mediar Partner to Develop Antibody Therapies for Fibro-Inflammatory Diseases

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

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