Skip to content Skip to footer
Subscribe Now
NEWS

Ceribell Secures FDA Clearance for AI-Powered EEG Enhancements

Shots: The US FDA has granted 510(k) clearance to two AI algorithm enhancements, Epileptiform Abnormality Detection & Artifact Reduction, which are integrated into its cloud-based Neurology Portal The Artifact Reduction algorithm identifies interference from patient movement, medical equipment, and physiological signals, while Epileptiform Abnormality Detection flags abnormal patterns across lengthy EEG recordings, helping neurologists navigate…
August 11, 2026

Read more

NEWS

Oculis to Acquire Full Global Rights to Privosegtor from Accure Therapeutics

Shots: Oculis will acquire Accure’s worldwide development & commercial rights to Privosegtor (ACT-01), terminating its existing license & giving Oculis greater control and economic upside as the neuro-ophthalmology asset advances Deal also incl. ACT-02, a preclinical neurology candidate. Total consideration incl. $3.8M upfront cash & ~2.05M Oculis shares, incl. milestone-linked shares. Closing is expected by…
August 10, 2026

Read more

NEWS

Curium and Lantheus to Merge in an ~$8B Deal

Shots: Lantheus to merge with a wholly-owned subsidiary of Curium US, combining Curium’s global theranostics platform with Lantheus’ US radiodiagnostics business; closing expected in H1’27 As per the deal, Curium will acquire Lantheus for $102.5/share in cash, with shareholders eligible for ~$12/share in non-transferable CVRs, representing total consideration of up to $114.50/share & a transaction…
August 4, 2026

Read more

INSIGHTS+

EMA Marketing Authorization of New Drugs in June 2026    

Shots:  The European Medicines Agency (EMA) advanced multiple marketing authorizations and positive opinions in June 2026 across oncology, neurology, rare diseases, metabolic disorders, and infectious diseases, involving companies including Amgen, Immedica, Sanofi, Arrowhead Pharmaceuticals, Acadia Pharmaceuticals, and Zambon.  European Commission approvals included Imdylltra for extensive-stage small cell lung cancer (ES-SCLC), Zepzelca + Tecentriq as a first-line maintenance therapy for ES-SCLC, Cenrifki for secondary progressive…
July 21, 2026

Read more

NEWS

Viz.ai Partners with Cortechs.ai to Expand AI Platform into Neurodegenerative Disease Care

Shots: Viz.ai has partnered with Cortechs.ai to integrate its NeuroQuant & NeuroQuant MS into its AI-powered care coordination platform, expanding into neurodegenerative diseases The collaboration will initially focus on multiple sclerosis by integrating Cortechs.ai’s quantitative MRI analysis into Viz.ai’s clinical workflow & care coordination platform to improve MS identification, characterization, & management The company plans…
July 10, 2026

Read more

NEWS

Splash Licenses Argent BioPharma’s CannEpil for Global Epilepsy Rights

Shots: Splash secured exclusive global rights to develop & commercialize CannEpil for drug-resistant epilepsy, refractory epilepsy, seizure disorders, & related neurological conditions, incl. future product improvements & next-generation formulations Splash secured a $1M strategic investment from C/M Capital Partners, while Mercer Street forgave ~$5M in Argent BioPharma debt and Splash issued $5.5M in preferred equity…
July 7, 2026

Read more

Axsome
NEWS

Axsome Therapeutics Reports the US FDA Approval of Auvelity to Treat Agitation Associated with Alzheimer’s Dementia

Shots: The US FDA has approved Auvelity (dextromethorphan HBr & bupropion HCl) for the treatment of agitation associated with dementia due to Alzheimer’s disease Approval was supported by an extensive clinical program incl. P-III (ADVANCE-1 & ACCORD-2), where ADVANCE-1 evaluated Auvelity vs PBO or bupropion over 5wks., while ACCORD-2 assessed Auvelity vs PBO in known responders In…
May 1, 2026

Read more

NEWS

Tanabe Pharma Report the EC Approval of Onerji for Parkinson’s Disease (PD) 

Shots:  The EC has approved Onerji (levodopa/carbidopa) infusion for advanced PD pts with uncontrolled motor fluctuations. The therapy is being developed by its wholly owned subsidiary, NeuroDerm   Approval was based on the global P-III (BouNDless) trial, which demonstrated Onerji + supplemental oral LD/CD significantly increased ON time without troublesome dyskinesia and reduced OFF time vs immediate-release oral LD/CD. Favourable long-term safety and tolerability results were also observed in the…
April 27, 2026

Read more

INSIGHTS+

2025 EMA Drug Approvals Outlook: A Year of Intentional, Biology Led Medicine Across Europe 

Shots:  EMA approvals in 2025 reinforce a biology-first regulatory standard, favoring mutation-exact, genotype-defined, and severity-weighted therapies that narrow indications, elevate rare diseases, and reward durability of benefit over rapid market expansion  Convenience at the EMA is no longer cosmetic, it is integral to benefit–risk assessment, with oral, subcutaneous, and low-burden dosing strategies increasingly tied to adherence, long-term outcomes,…
January 22, 2026

Read more

Load more