NEWS

Zimmer Biomet Receives FDA 510(k) Clearance for ROSA Knee with OptimiZe

Shots: The US FDA has granted 510(k) clearance to ROSA Knee with OptimiZe, an enhanced version of the ROSA Knee system designed to support accurate, reproducible outcomes in robotic-assisted knee replacement surgery, with targeted rollout planned for late 2025 & broader US availability expected in Q1’26 The system introduces new features, incl. customizable surgical plan,…

November 17, 2025

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

Sanofi’s Teizeild (Teplizumab) Receives the CHMP’s Positive Opinion to Delay Progression of Type 1 Diabetes

Shots: The CHMP has recommended Teizeild to delay the onset of stage 3 type 1 diabetes (T1D) in adult & pediatric pts (≥8yrs.) with stage 2 T1D; regulatory review is ongoing in the other regions Opinion was based on the P-II (TN-10) trial assessing Teizeild (QD, n=44) vs PBO (n=32) for 14 days in 76…

November 17, 2025

Merck to Acquire Cidara Therapeutics for ~$9.2B to Bolster Antiviral Pipeline

Shots: Merck has signed a definitive agreement to acquire Cidara Therapeutics through a subsidiary, adding the company’s lead late-stage antiviral candidate CD388 to its pipeline Merck will acquire Cidara at $221.50 per share in cash, valuing the deal at approximately $9.2B. The transaction is expected to close in Q1’26 Cidara’s CD388 (currently in P-III) is…

November 17, 2025

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

Lundbeck Reports the MHLW’s NDA Acceptance of Vyepti (Eptinezumab) for the Preventive Treatment of Migraine

Shots: The Japanese MHLW has accepted an NDA of Vyepti for the treatment of pts living with migraine, who are eligible for preventive therapy; regulatory review is also ongoing in China & South Korea The NDA was supported by extensive clinical data, incl. the P-III (SUNRISE) trial of Vyepti (100 or 300mg, IV) vs PBO…

November 14, 2025

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

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

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

Eisai and BioArctic Report the MHRA Approval of Leqembi (Lecanemab) as a Maintenance Therapy to Treat Early Alzheimer’s Disease

Shots: The UK’s MHRA has approved Leqembi (IV, Q4W) as a maintenance therapy for early Alzheimer’s pts after completing 18mos. of Q2W Leqembi treatment Leqembi is approved in 51 countries for early AD & under review in 9, while the Q4W maintenance is approved in the UK, China, the US, & others, with 4 applications…

November 14, 2025

NEWS

Zimmer Biomet Receives FDA 510(k) Clearance for ROSA Knee with OptimiZe

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

Sanofi’s Teizeild (Teplizumab) Receives the CHMP’s Positive Opinion to Delay Progression of Type 1 Diabetes

Merck to Acquire Cidara Therapeutics for ~$9.2B to Bolster Antiviral Pipeline

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

Lundbeck Reports the MHLW’s NDA Acceptance of Vyepti (Eptinezumab) for the Preventive Treatment of Migraine

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

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

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

Eisai and BioArctic Report the MHRA Approval of Leqembi (Lecanemab) as a Maintenance Therapy to Treat Early Alzheimer’s Disease

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