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Michael Rodriguez is a Managing Editor for United States & Americas pharmaceutical intelligence editor on NovaPharmaNews, with 732 published articles covering FDA regulatory actions, clinical development, and market-moving news. Journalist specializing in FDA approvals and biotech coverage. Previously covered pharma and biotech for Reuters Health.
About Michael Rodriguez
Journalist specializing in FDA approvals and biotech coverage. Previously covered pharma and biotech for Reuters Health.
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Topics and beats Michael covers across United States & Americas.
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Articles by Michael Rodriguez
Creatinine Clearance Calculation — Help & Usage Guide
Estimate creatinine clearance and assess renal function with our calculator. Accurately evaluate kidney function to excrete waste products effectively.
Biotech’s coming of age: AI, capital efficiency and China reshape the field
Biotech’s coming of age is being framed by three documented shifts: investor caution, AI-driven efficiency, and China’s growing role in drug development. This plan keeps the article tightly grounded in Nature Biotechnology and PubMed-confirmed facts.
Celiac disease therapies enter a new era of innovation
New therapies in celiac disease are advancing as the field moves beyond diet-only management. Current evidence also highlights updated diagnostic thinking and a shift toward drugs in advanced clinical phases.
Neumora navacaprant fails Phase 3 as EnGene cuts 50% of staff
Neumora is discontinuing navacaprant after two Phase 3 failures in major depressive disorder and is laying off 35% of its workforce. The available evidence also shows the program’s key Phase 3 studies and the drug’s mechanism.
Global hematology trials keep research patient-centered and regionally relevant
Global hematology trials are increasingly framed around translational research and patient-centered outcomes. Regulators and trial designers must coordinate across regions as drug development globalizes.
FDA authorizes emergency pet treatment for New World screwworm
The FDA issued Emergency Use Authorizations for NexGard and NexGard COMBO to treat New World screwworm in dogs and cats. Reuters also reported emergency use for nitenpyram tablets in pets meeting weight and age thresholds.
Hillhurst Bio doses first subject in Phase 2a HBI-002 Parkinson's trial
Hillhurst Bio doses first subject in a Phase 2a clinical trial of HBI-002 for Parkinson's disease. The study is recruiting and is listed on ClinicalTrials.gov as a randomized, double-blind, placebo-controlled multiple-dose trial.
FDA approves belzutifan plus pembrolizumab for adjuvant RCC
The FDA approved belzutifan plus pembrolizumab as adjuvant therapy for clear cell renal cell carcinoma at high risk of recurrence after nephrectomy. The catalyst is based on phase 3 LITESPARK-022 data and adds another regulatory milestone for belzutifan.
Prescription Drug Freight Fraud June 2026 report: what the record shows
Prescription Drug Freight Fraud June is a grounded summary of what the June 2026 report and cited U.S. regulatory records confirm. It covers the documented FTC lawsuit and the Federal Register notice without adding unsupported claims.
FDA MRD guidance in multiple myeloma: what BD teams should track
The FDA has issued draft guidance on using MRD and complete response as endpoints in multiple myeloma trials. This plan frames what changed, why MRD matters for accelerated approval, and what BD teams and investors should watch next.
Alembic Wins Tentative FDA Nod for First Generic Larotrectinib Capsules
Alembic Pharmaceuticals received tentative FDA approval for generic larotrectinib capsules in 25 mg and 100 mg strengths. The move marks a key catalyst for Vitrakvi competition, with final launch timing still dependent on remaining patent or exclusivity issues.
FDA Clears First OTC CGM for Children: Dexcom Expands Stelo
The FDA has cleared Dexcom Inc.’s Stelo Glucose Biosensor System as the first over-the-counter continuous glucose monitor for children. The decision extends Stelo’s prior OTC clearance in adults and gives analysts a new regulatory catalyst to track in diabetes monitoring.
Chile warning labels on food: new evidence on efficacy and obesity risk
Chile warning labels on food are back in focus as new reporting adds child obesity data to an established evidence base on purchase shifts. For B2B readers, the key question is whether Chile food labels continue to shape regulation, consumer behavior, and adjacent policy debates.
Socioeconomic status shapes children’s brain development, study finds
Study highlights influence of socioeconomic status on children’s brain development, based on brain scans from nearly 12,000 children ages 9 to 10. The findings reinforce prior research on socioeconomic status and structural brain development and cognitive development.
FDA adds bemotrizinol to sunscreen rules, expanding U.S. UV filter options
FDA regulates sunscreens as OTC drug products and, in June 2026, added bemotrizinol as a permitted active ingredient. The change expands the available options for safe and effective sun protection products. Proper sunscreen use remains relevant to reducing sunburn, skin cancer, and early skin aging risk.
CDC data show alcohol use during pregnancy is rising again
CDC data suggest alcohol use during pregnancy increased after 2020, rising from 13.5% in 2021 to 15% in 2024. The findings reinforce that alcohol during pregnancy remains an active public health concern, not a solved one.
Takeda TYK2 drug tops Bristol Myers’ Sotyktu in psoriasis head-to-head test
Takeda’s TYK2 inhibitor zasocitinib outperformed Bristol Myers Squibb’s Sotyktu in a head-to-head plaque psoriasis trial. The result strengthens Takeda’s dermatology story and gives BD teams and investors a clearer read on the program’s competitive position.
FDA authorizes generic nitenpyram for New World screwworm in pets
FDA issued an Emergency Use Authorization for generic Nitenpyram Tablets to treat New World screwworm infestations in dogs, puppies, cats, and kittens. The authorization covers pets at least four weeks old and weighing at least two pounds.
Medicare GLP-1 coverage 2026: Bridge program starts July 1
CMS will launch a temporary Medicare GLP-1 Bridge program on July 1, 2026, creating a new access pathway for eligible beneficiaries. For BD teams, investors, and analysts, the key questions are coverage scope, pricing pressure, and what the demo signals for future reimbursement.
FDA Drug Approval: What Approval Means for Pharma Marketing and BD
FDA approval means the agency has determined a drug’s benefits outweigh its risks for the intended use. This plan explains what approval allows, how NDAs are reviewed, and why that matters for BD teams, investors, and analysts.
Nektar Therapeutics pipeline update: REZPEG, amphotericin B and UK site changes
Nektar Therapeutics’ pipeline remains centered on REZPEG, with active Phase 2 programs in atopic dermatitis and alopecia areata and a completed SLE study. The company also has an amphotericin B-linked program context and recent business changes that matter for BD teams and investors.
Sanofi pipeline pdf: Dupixent, Lantus and 2026 catalysts
This plan frames a Sanofi pipeline pdf-style news brief around 2026 clinical catalysts, with Dupixent as the anchor asset and Lantus as a mature revenue base. It also clarifies the Sanofi Pasteur MSD joint venture structure and why the pipeline matters for analysts and BD teams.
Alnylam pipeline update: AMVUTTRA catalysts, outlook and profitability
Alnylam pipeline momentum is anchored by AMVUTTRA’s FDA-approved ATTR-CM and hATTR-PN uses, plus two active Phase 3 catalysts. The update focuses on what changed, what it means for investors, and what to watch next.
Arcus Biosciences pipeline update: casdatifan, quemliclustat, domvanalimab
Arcus Biosciences’ pipeline centers on casdatifan in kidney cancer, quemliclustat in pancreatic cancer, and domvanalimab in lung cancer. This plan focuses only on sourced pipeline facts and cited clinical-trial catalysts.
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