Skip to content Skip to footer
Subscribe Now
Ionis and Otsuka
NEWS

The CHMP Recommends Ionis and Otsuka’s Dawnzera (Donidalorsen) as a Prophylactic Treatment of Hereditary Angioedema (HAE)

Shots: The CHMP has recommended Dawnzera for the routine prevention of HAE attacks in pts (≥12yrs.) following the US FDA approval in Aug 2025; EC’s decision is expected in Q1’26 Opinion was based on P-III (OASIS-HAE) trial & OASISplus study, showing improvements across multiple domains, incl. sustained reduction in mean monthly HAE attack rate even when Dawnzera…
November 17, 2025

Read more

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Nov 10, 2025 – Nov 14, 2025)     

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, and Biosimilars. Check out our full report below:     Ionis Highlights P-III (CORE & CORE2) Trials Results of Olezarsen for Severe Hypertriglyceridemia (sHTG) at AHA 2025  Read More: Ionis  AstraZeneca Reports P-III (NATRON) Trial Data on Fasenra (Benralizumab) to Treat Hypereosinophilic Syndrome (HES) …
November 14, 2025

Read more

NEWS

Adagene Enters ~$845M Licensing Deal with Third Arc Bio to Develop Masked CD3 T Cell Engagers

Shots: Third Arc Bio has entered into a licensing agreement with Adagene to utilize its SAFEbody technology platform for generating masked CD3 T cell engagers against unique tumor-associated antigens As per the deal, Third Arc Bio will gain global rights to research, develop & commercialize 2 candidate molecules, while Adagene will receive a no-cost option…
November 14, 2025

Read more

NEWS

Outlook Therapeutics Reports the US FDA’s BLA Acceptance of ONS-5010 to Treat Wet Age-Related Macular Degeneration (wAMD)

Shots: The US FDA has accepted the resubmitted BLA of ONS-5010 (bevacizumab-vikg) for the treatment of wAMD, considering a Class 1 review & granting a PDUFA goal date Dec 31, 2025; if approved, it will be branded Lytenava ONS-5010 (intravitreal) is an ophthalmic bevacizumab formulation that binds all VEGF isoforms to block VEGF interaction with…
November 14, 2025

Read more

Kura Oncology and Kyowa Kirin
NEWS

Kura Oncology and Kyowa Kirin Report the US FDA’s Approval Komzifti (Ziftomenib) for NPM1-Mutated Acute Myeloid Leukemia (AML)

Shots: The US FDA has granted full approval to Komzifti (QD, PO) to treat adults with r/r AML with NPM1 mutation who have no satisfactory alternative treatment options before the PDUFA date of Nov 30, 2025 Approval was backed by P-I/II (KOMET-001) trial in 112 r/r NPM1-mutant AML pts, showing 21.4% CR + CRh with a median…
November 14, 2025

Read more

NEWS

Rapid Nexus Reports the US FDA’s 510(k) Clearance of Hemastyl Gel Device to Support Wound Healing

Shots: The US FDA has granted 510(k) clearance to the Hemastyl gel device to support chronic wound healing  The Hemastyl gel is a topical formulation that enhances the tissue-repair environment to support wound closure, while the Periwound NerveStim device works with Hemastyl to restore periwound function The Periwound NerveStim device is in final FDA approval stages, with…
November 14, 2025

Read more

Load more