FDA Backs Domestic Drug Production to Counter China
The FDA has proposed policies to boost domestic drug manufacturing, including giving U.S. generic makers a patent challenge head start over foreign rivals.
Keala Nakamura
Editor-in-Chief
Clinical Research MethodologyInternal MedicineEvidence-Based MedicineEditorial Leadership
About Keala
Keala Nakamura is an internal medicine specialist and clinical researcher at Queen's Medical Center, Honolulu. Previously on the editorial staff of the New England Journal of Medicine, she brings two decades of experience in clinical research methodology and evidence-based medicine to her role leading Hawaii Medical Journal. Previously, Keala was a Communications Specialist at American Medical Association. Keala holds a B.S. in Public Health from University of Hawaii at Manoa.
Articles by Keala
FDA Delay Forces Kezar Life Sciences to Close Its Doors
A four-month FDA meeting cancellation proved fatal for Kezar Life Sciences, highlighting how regulatory delays can devastate small biotech companies.
FDA Delays Force Kezar Life Sciences to Shut Down
Kezar Life Sciences is winding down after FDA meeting cancellations disrupted its autoimmune hepatitis drug program, driving investors to withdraw funding.
FDA Approves Lilly's Orforglipron; Trump Pharma Tariffs Loom
FDA approves Eli Lilly's oral obesity pill orforglipron (Foundayo) while Trump eyes 100% tariffs on imported pharmaceuticals and drug ingredients.
Pharma Delays European Drug Launches Over US Pricing Policy
Drug manufacturers are delaying European launches as most-favored-nation pricing threatens to compress US revenues, reshaping global launch strategies in 2026.
Sarepta Therapeutics Shares Surge on Rare Disease Drug Data
Sarepta Therapeutics shares rose 20% after releasing early clinical data for two rare muscle-wasting disease candidates, SRP-1001 and SRP-1003.
Novo Nordisk Faces Investor Pressure at 2026 Annual Meeting
Novo Nordisk faces shareholder scrutiny as its stock drops 45% since CEO ouster, while rival Eli Lilly surges to a $1 trillion market cap.
Court Ruling Reverses RFK Jr.'s Vaccine Policy Changes
A federal judge reversed HHS vaccine policy changes by RFK Jr., restoring the childhood vaccine schedule and creating a crossroads for the Trump administration.
VATS vs Open Lobectomy Survival: IPD Meta-Analysis
A Lancet IPD meta-analysis finds VATS lobectomy significantly improves overall survival versus open thoracotomy in early-stage NSCLC patients.
Surgical Approach and Long-Term Lung Cancer Outcomes 2026
A Lancet commentary argues surgical technique is a key variable in lung cancer outcomes, urging rigorous trial design to evaluate minimally invasive approaches.
Creatinine vs Cystatin C GFR Accuracy in Moderate CKD
A BMJ cohort study finds combined creatinine and cystatin C equations outperform creatinine-alone GFR estimates in monitoring moderate chronic kidney disease.
Medicare Chief: TrumpRx Is Narrow in Scope, Not a Full Fix
Medicare chief Chris Klomp says TrumpRx is a limited cash-pay tool, not a sweeping drug pricing overhaul, tempering Trump's transformative claims.
Trump Drug Pricing & GSK Asthma Inhaler Controversy 2026
The White House pushes most-favored-nation drug pricing legislation while a Senate report scrutinizes GSK's asthma inhaler discontinuation strategy.
Oral Obesity Pill Phase 2 Results & Cholesterol Guidelines 2026
Structure Therapeutics reports 16% weight loss in Phase 2 oral GLP-1 trial, plus GSK's Arexvy expansion and new cholesterol guideline updates.
Prenatal Antiseizure Drugs & Neurodevelopmental Risk in Kids
A large US cohort study finds valproate and zonisamide carry the highest neurodevelopmental risks in children exposed prenatally to antiseizure medications.
Jewish Doctor Suspended for Islamophobic Comments in UK
A UK tribunal suspended GP Cinderella Nonoo-Cohen for four months after she made Islamophobic remarks toward a Muslim colleague on a WhatsApp forum.
Martha's Rule: 446 Lifesaving NHS Interventions in 16 Months
NHS England reports 446 potentially lifesaving interventions in 16 months under Martha's Rule, the patient-initiated clinical escalation pathway launched in 2024.
FDA Advisory Committees Decline & Biosimilar Rule Changes
FDA faces scrutiny over a 63% drop in advisory committee meetings in 2025 and new moves to ease biosimilar development requirements in 2026.
FDA Official Vinay Prasad to Step Down Next Month Following Controversial Tenure
Food and Drug Administration official Vinay Prasad will step down from his position next month following a series of controversial decisions regarding vaccines and gene therapies, according to an FDA announcement made Friday evening.
Trump's Drug Discount Platform TrumpRx Shows Limited Results One Month After Launch
President Trump's signature drug discount platform, TrumpRx, has delivered few available medications and unclear usage data one month after its highly publicized launch, according to a new report.
Emergency Room Tylenol Orders for Pregnant Women Drop 10% Following Trump Administration Autism Warning
Emergency departments across the United States saw a significant drop in acetaminophen orders for pregnant women following President Trump's September warning linking the common painkiller to autism, according to a new study published Thursday in The Lancet.
Hawaii Autism Researchers Join Independent Group Challenging Federal Committee's Vaccine-Autism Focus
A coalition of autism researchers and advocates announced Tuesday the formation of an independent advisory body aimed at countering a federal committee that includes members who believe childhood vaccines cause autism, despite scientific evidence to the contrary.