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…

ByRidhi RastogiAugust 10, 2026

NEWS

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

NEWS

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

NEWS

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…

ByRidhi RastogiAugust 7, 2026

NEWS

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

NEWS

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…

ByRidhi RastogiAugust 7, 2026

NEWS

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

NEWS

Tarsus Pharmaceuticals to Acquire Alkeus Pharmaceuticals for ~$800M

Shots: Tarsus Pharmaceuticals has entered into a definitive agreement to acquire Alkeus Pharmaceuticals, incl. its lead asset gildeuretinol (ALK-001), expanding Tarsus’ presence in retina care As per the deal, Alkeus will receive ~$450M upfront ($270M cash + $180M in Tarsus stock priced at $61.38/share), plus ~$350M in regulatory & commercial milestones, & low single-digit tiered descending…

ByRidhi RastogiAugust 6, 2026

NEWS

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

NEWS

Alteogen Licenses ALT-B4 to a Global Pharmaceutical Company in a ~$365M Deal

Shots: Alteogen has entered into an exclusive license agreement with a global pharmaceutical company to develop & commercialize a SC formulation of a biologic product utilizing ALT-B4 (berahyaluronidase alfa) As per the deal, the company will acquire exclusive global rights to the SC formulation of a biologic product. In exchange, Alteogen will receive ~$365M, incl.…

ByRidhi RastogiAugust 6, 2026

Ridhi Rastogi

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

Tarsus Pharmaceuticals to Acquire Alkeus Pharmaceuticals for ~$800M

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

Alteogen Licenses ALT-B4 to a Global Pharmaceutical Company in a ~$365M Deal

Contact US

FOLLOW US