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

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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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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

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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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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

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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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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

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Schrödinger and Bristol Myers Squibb Expand AI Collaboration with Bunsen

Shots: Schrödinger has entered into a strategic agreement with BMS to deploy Bunsen, its agentic AI co-scientist, across BMS's research organization, expanding the companies' long-standing partnership As per the deal, Schrödinger will work with BMS to develop new Bunsen capabilities alongside its computational technologies for large-scale chemical exploration & RetroSynth, its AI-driven synthesis planning platform …

ByRidhi RastogiAugust 6, 2026

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BlueWind Medical Receives FDA Clearance for Revi Extend Implant

Shots: The US FDA has granted 510(k) clearance to Revi Extend, the next-generation implant for Revi System to treat urgency urinary incontinence (UUI), with the new implant offering an extended lifespan of 15yrs.Limited US launch planned for Q4’26 Built on Implantable Tibial Neuromodulation (ITNM), Revi System is designed to reduce the long-term treatment burden through…

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

Ridhi Rastogi

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

Schrödinger and Bristol Myers Squibb Expand AI Collaboration with Bunsen

BlueWind Medical Receives FDA Clearance for Revi Extend Implant

Takeda Reports US FDA Approval of Orzeyful (Oveporexton) for Narcolepsy Type 1

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