Market & Regulatory Insight

Regulatory Intelligence

Understanding the approval landscape is foundational to commercialization strategy. We track recent approvals across drugs, biologics, and medical devices to inform the regulatory positioning and market entry work we do with clients — and to help the companies we work with understand where their asset fits in the current landscape.

This reference reflects the regulatory environment Rokline monitors on behalf of clients pursuing US market entry. It is one input among many in the commercialization work we do — not a standalone service.

Showing 12 results

Leqembi (lecanemab-irmb)

Drugs

Treatment of Alzheimer's disease in adults with mild cognitive impairment or mild dementia.

Sponsor

Eisai / Biogen

Therapeutic Area

Neurology

Approval Date

July 6, 2023

Pathway

Traditional Approval

Skyclarys (omaveloxolone)

Drugs

Treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older.

Sponsor

Reata Pharmaceuticals

Therapeutic Area

Rare Disease

Approval Date

February 28, 2023

Pathway

Accelerated Approval

Hemgenix (etranacogene dezaparvovec)

Biologics

Treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy.

Sponsor

CSL Behring

Therapeutic Area

Rare Disease

Approval Date

November 22, 2022

Pathway

Traditional Approval

Mounjaro (tirzepatide)

Drugs

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Sponsor

Eli Lilly

Therapeutic Area

Endocrinology

Approval Date

May 13, 2022

Pathway

Traditional Approval

Opdualag (nivolumab + relatlimab)

Drugs

Treatment of unresectable or metastatic melanoma in adults and pediatric patients 12 years or older.

Sponsor

Bristol Myers Squibb

Therapeutic Area

Oncology

Approval Date

March 18, 2022

Pathway

Traditional Approval

Carvykti (ciltacabtagene autoleucel)

Biologics

Treatment of relapsed or refractory multiple myeloma in adults.

Sponsor

Janssen / Legend Biotech

Therapeutic Area

Oncology

Approval Date

February 28, 2022

Pathway

Accelerated Approval

Zynrelef (bupivacaine + meloxicam)

Drugs

Postsurgical analgesia for up to 72 hours following soft tissue and orthopedic surgical procedures.

Sponsor

Heron Therapeutics

Therapeutic Area

Cardiology

Approval Date

May 26, 2021

Pathway

Traditional Approval

Lumipulse G600II

Medical Devices

In vitro diagnostic device for detection of Alzheimer's disease biomarkers in cerebrospinal fluid.

Sponsor

Fujirebio Diagnostics

Therapeutic Area

Neurology

Approval Date

May 5, 2022

Pathway

510(k) Clearance

Aduhelm (aducanumab)

Drugs

Treatment of Alzheimer's disease. First therapy to target amyloid plaques.

Sponsor

Biogen

Therapeutic Area

Neurology

Approval Date

June 7, 2021

Pathway

Accelerated Approval

Spikevax (mRNA-1273)

Biologics

Prevention of COVID-19 caused by SARS-CoV-2 in individuals 18 years and older.

Sponsor

Moderna

Therapeutic Area

Infectious Disease

Approval Date

January 31, 2022

Pathway

Traditional Approval

Vyjuvek (beremagene geperpavec)

Biologics

Treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa.

Sponsor

Krystal Biotech

Therapeutic Area

Rare Disease

Approval Date

May 19, 2023

Pathway

Traditional Approval

Zavzpret (zavegepant)

Drugs

Acute treatment of migraine with or without aura in adults.

Sponsor

Pfizer

Therapeutic Area

Neurology

Approval Date

March 9, 2023

Pathway

Traditional Approval

This reference is provided for informational purposes only. Rokline Health Concepts LLC makes no representations regarding completeness or accuracy. For authoritative approval information, consult the FDA's official Drugs@FDA database.

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