The US FDA New Drug Approvals in February 2026

Shots: Approval momentum strengthened in February 2026, with the US FDA clearing four new therapies across dermatology, psychiatry, and rare pediatric disorders highlighting both volume and therapeutic impact. Four notable therapies crossed the regulatory finish line, Acrotech Biopharma and Otsuka Pharmaceutical’s Adquey for mild-to-moderate atopic dermatitis, Vanda Pharmaceuticals’ Bysanti for acute bipolar I disorder and schizophrenia, Immedica Pharma’s Loargys for ARG1-D–related hyperargininemia, and Ascendis Pharma’s Yuviwel to improve growth in children with achondroplasia Overall, February 2026 reflected…

ByDipanshu DixitMarch 10, 2026

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CapsoVision Reports US FDA 510(k) Submission for AI-Assisted Reading Module in CapsoCam Plus

Shots: The company has submitted a 510(k) application to the US FDA for its proprietary AI-assisted module designed for use with CapsoCam Plus The CapsoCam Plus capsule endoscopy system is designed to visualize small bowel mucosa and detect abnormalities in adults and children (age ≥ 2 yrs) The reading tool is expected to improve the…

ByDipanshu DixitJanuary 1, 2026

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Aptar Reports the US FDA Approval of Cardamyst (Etripamil) for PSVT

Shots: The US FDA has approved Aptar’s Cardamyst (Etripamil), developed by Milestone Pharmaceuticals, for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults Cardamyst (Intranasal) is a Bidose (BDS) Liquid Nasal Spray System Aptar collaborated with Milestone Pharmaceuticals to design a custom polypropylene container closure system with an…

ByDipanshu DixitDecember 17, 2025

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New Drug Designations – May 2025  

Shots:    PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada and NMPA  The May 2025 report covers designations granted to 44 drugs and 5 medical devices, spanning 15 small molecules, 7 biologics, 13 cell and gene therapies & 5 medical devices among others  …

ByDipanshu DixitJune 24, 2025

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CoreMap Reports the US FDA’s IDE Approval for CoreMap’s EP Map-Guided AF Ablation Study

Shots: CoreMap received the US FDA’s IDE approval of CoreMap EP (Endocardial Electrophysiology) to extend the 3-phase INvENI clinical study into the US in pts with Atrial Fibrillation (AF) and long-standing persistent AF The P-I study assessed acute safety of CoreMap EP in 14 pts while P-II study showed acute safety & effectiveness in 15 pts. The…

ByRidhi RastogiMay 30, 2025

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New Drug Designations – October 2024

Shots: PharmaShots' designation report provides a concise overview of the latest drug designations by major regulatory authorities, including the FDA, NMPA, and EMA The October 2024 report covers designations granted to 33 drugs and 2 devices, encompassing 14 small molecules, 4 biologics, 8 cell and gene therapies, and 2 medical devices. Significant trends this month…

BySaurabh ChaubeyNovember 26, 2024

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New Drug Designations – September 2024

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA, Health Canada and EMA. The September 2024 report covers regulatory designations for 42 drugs and 1 device, including 16 small molecules, 6 biologics, 12 cell and gene therapies, and 1 device, among others. Significant trends this month…

BySaurabh ChaubeyOctober 29, 2024

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Fresenius Kabi and Formycon Report the US FDA’s Approval of Otulfi (Biosimilar, Stelara)

Shots: The US FDA has approved Otulfi (SC & IV), biosimilar of Stelara (ustekinumab), to treat Crohn’s disease, ulcerative colitis, mod. to sev. plaque PsO & active psoriatic arthritis. Fresenius Kabi can market Otulfi by Feb 22, 2025 Approval was based on analytical, pre-clinical, clinical & manufacturing data, showing similar efficacy, safety, PK & immunogenicity…

ByDipanshu DixitSeptember 30, 2024

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Tanvex BioPharma Reports the US FDA’s Approval of Nypozi (Biosimilar, Neupogen)

Shots: The US FDA has granted BLA approval of Nypozi (TX01), biosimilar version of Amgen’s Neupogen Nypozi (TX01) is intended to reduce the incidence of infection among patients having non-myeloid malignancies undergoing chemotherapy that may reduce neutrophil count The company’s Nypozi was introduced across Canada in Jan 2024 Ref: Tanvex BioPharma | Image: Tanvex BioPharma | Press Release…

ByDipanshu DixitJuly 1, 2024

NEWS

Fresenius Reports the US FDA’s BLA Acceptance of FKS518 (Biosimilar, Denosumab)

The US FDA has accepted the BLA of the company’s FKS518, a biosimilar product of Prolia (denosumab) and Xgeva (denosumab) The BLA was supported by the analytical development & similarity evaluation data from two trials comparing FKS518’s pharmacokinetic profile in one while efficacy and safety in another study with the reference FKS518 is indicated for…

ByDipanshu DixitMay 27, 2024

The US FDA New Drug Approvals in February 2026

CapsoVision Reports US FDA 510(k) Submission for AI-Assisted Reading Module in CapsoCam Plus

Aptar Reports the US FDA Approval of Cardamyst (Etripamil) for PSVT

New Drug Designations – May 2025

CoreMap Reports the US FDA’s IDE Approval for CoreMap’s EP Map-Guided AF Ablation Study

New Drug Designations – October 2024

New Drug Designations – September 2024

Fresenius Kabi and Formycon Report the US FDA’s Approval of Otulfi (Biosimilar, Stelara)

Tanvex BioPharma Reports the US FDA’s Approval of Nypozi (Biosimilar, Neupogen)

Fresenius Reports the US FDA’s BLA Acceptance of FKS518 (Biosimilar, Denosumab)

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