SUBSCRIBE
SUBSCRIBE
Tristan Manalac

Tristan Manalac

Senior Staff Writer

Tristan is BioSpace‘s senior staff writer. Based in Metro Manila, Tristan has more than eight years of experience writing about medicine, biotech and science. Being formally trained in molecular biology, he once dreamed of collecting degrees and starting his own lab. But these days, he finds his greatest joy in a bottle of beer and a beautiful sentence. He can be reached at tristan.manalac@biospace.com, tristan@tristanmanalac.com or on LinkedIn.

A contemporary artistic collage featuring a hand holding a trophy. The concept of victory and achievement.
Clinical research
5 of 2025’s Defining Clinical Wins
In the midst of regulatory and political upheaval, biopharma’s R&D engine kept running, churning out highs and lows in equal parts. Here are some of this year’s most glorious clinical trial victories.
December 15, 2025
 · 
9 min read
 · 
Tristan Manalac
A scientist with pill bottles in front of FDA headquarters
Regulatory
FDA Action Alert: GSK, Aldeyra, Rhythm and More
Coming up in the back half of December, the FDA will issue a verdict on Vanda Pharmaceuticals’ gastroparesis drug tradipitant, which it rejected last September, triggering a very public dispute with the company.
December 15, 2025
 · 
5 min read
 · 
Tristan Manalac
Target, miss the target, target shooting, dart, correct decisions, bow and arrow, dart on target, hits and misses (3d illustration)
Clinical research
The 5 Most Painful Clinical Trial Failures of 2025
Every year in biopharma brings its share of grueling defeats, and 2025 was no different, especially for companies targeting neurological diseases. Some failures split up partners, and one particularly egregious case even led to the demise of an entire company.
December 15, 2025
 · 
9 min read
 · 
Tristan Manalac
Pictured: Illustration of antibodies attacking a nerve cell
Approvals
Amgen Scores Uplizna Expansion Into Generalized Myasthenia Gravis
Generalized myasthenia gravis is Uplizna’s second new indication this year, after the FDA cleared the anti-CD19 antibody for IgG4-related disease in April.
December 12, 2025
 · 
2 min read
 · 
Tristan Manalac
Hands in black and white dropping a collection of pills on a pink background
Approvals
GSK’s Blujepa Opens First New Class of Gonorrhea Antibiotic in More Than 30 Years
Blujepa is also approved for uncomplicated urinary tract infection in females 12 years and older.
December 12, 2025
 · 
2 min read
 · 
Tristan Manalac
Close-Up Of Syringe With Bottles Against Blue Background
Vaccines
CDC Highlights Efficacy of COVID-19 Shots in Kids Amid FDA Probe of Alleged Deaths
The 2024–2025 formulations of COVID-19 vaccines had an effectiveness rate of 76% at preventing emergency or urgent care visits in children aged 9 months through four years, according to a new report.
December 12, 2025
 · 
2 min read
 · 
Tristan Manalac
Pictured: Entrance to Pfizer's office in Belgium
Breast cancer
Pfizer Builds Case for Tukysa as ‘New Standard Regimen’ in First-Line Metastatic Breast Cancer
While new late-stage data point to some liver toxicity signals, analysts at BMO Capital Markets said Tukysa’s efficacy outcomes “appear to more than make up for any safety concerns.”
December 11, 2025
 · 
2 min read
 · 
Tristan Manalac
Creative collage illustration of financial business. Two businessmen shaking hands for partners agreement. Conceptual illustration of success deal, corporate ethic, connection.
Weight loss
Zealand Bets up to $2.5B in Metabolic Pact With Chinese Biotech
Also on Thursday, Zealand held its Capital Markets Day in London, outlining the strategy for its weight management franchise in the near-term, including launching five products by 2030.
December 11, 2025
 · 
2 min read
 · 
Tristan Manalac
Pictured: Roche Diagnostics building in California
Breast cancer
Roche’s Oral SERD Cuts Death Risk by 30% in Early-Stage Breast Cancer
While overall survival remains immature, results so far show a clear trend in favor of Roche’s giredestrant.
December 11, 2025
 · 
2 min read
 · 
Tristan Manalac
Pictured: Pfizer's signage outside its office in Canada/iStock, JHVEPhoto
Layoffs
Pfizer’s Cost Cuts Claim 200+ Jobs in Switzerland: Report
Pfizer is in the midst of an aggressive, multi-year cost-cutting effort, which so far has left nearly 2,000 people jobless.
December 11, 2025
 · 
2 min read
 · 
Tristan Manalac
Thumb up close-up in surgical, medical gloves, gesture, recommendation for a successful operation. Pink background.
Rare diseases
FDA Greenlights First Gene Therapy for Rare Pediatric Disease
Backed by Italy-based Fondazione Telethon ETS, Waskyra, for Wiskott-Aldrich syndrome, is the first gene therapy from a non-profit sponsor to win FDA approval.
December 10, 2025
 · 
1 min read
 · 
Tristan Manalac
Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS).
Vaccines
FDA Launches Probe Into Safety of Approved Anti-RSV Antibodies
The FDA has informed Merck, Sanofi and AstraZeneca of the safety investigation into their RSV antibodies, though it remains unclear what regulatory action, if any, will be taken.
December 10, 2025
 · 
2 min read
 · 
Tristan Manalac
Minimal Clip Art Collage. Pop Vector Design Composition with bright bold geometric shapes, halftone objects for ad, animation etc
Approvals
First Commissioner’s Priority Review Approval Goes to Decades-Old Antibiotic
The Commissioner’s National Priority Voucher program was launched in June to shorten review times for companies that align with various national priorities, such as improving domestic drug production and supply.
December 10, 2025
 · 
2 min read
 · 
Tristan Manalac
FDA signage at its headquarters in Maryland
FDA
CAR-T Developers Will Need Randomized Trials as FDA Eyes Tighter Approval Requirements
For traditional approval, CAR T therapies will need to establish superiority over current standard treatments, including already-approved CAR T products.
December 9, 2025
 · 
2 min read
 · 
Tristan Manalac
Closeup of businessman give money to robot. Man pass banknote bribe to robotic assistant. AI and technology. Vector illustration.
Immunology and inflammation
Novartis Unites With Relation in $1.7B Inflammatory Skin Disease Pact
At the heart of the deal is Relation’s Lab-in-the-Loop platform, which uses AI models to improve understanding of diseases and guide clinical development programs.
December 9, 2025
 · 
2 min read
 · 
Tristan Manalac
Load More