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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.

Illustration showing hurdles along a path ending in an arrow
Complete response letters
REGENXBIO’s Hunter Rejection Hinged on Inadequate Controls, Surrogate Endpoint
In a complete response letter published by the FDA on Monday, the agency said a resubmission for REGENXBIO’s Hunter syndrome gene therapy should provide evidence of normalized or improved biomarker levels or neurodevelopmental outcomes.
March 3, 2026
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2 min read
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Tristan Manalac
Pulsing heart collage illustration, sign of life. Isolated human heart organ with glowing red line surrounding, black and white
Rare disease
Aardvark Tanks After Pausing Prader-Willi Study on ‘Surprise’ Safety Signals
Aardvark Therapeutics is down 54% since Friday after the biotech said it detected “reversible cardiac observations” in a healthy volunteer study of its drug to treat extreme hunger in patients with the rare genetic disease.
March 2, 2026
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2 min read
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Tristan Manalac
Racing Cars at the finish line
Approvals
Ascendis Enters Achondroplasia Arena as FDA Approves First Weekly Drug
Yuviwel will compete with BioMarin’s Voxzogo. Meanwhile, BridgeBio is working to bring its own achondroplasia drug, the FGFR3 blocker infigratinib, to the market.
March 2, 2026
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2 min read
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Tristan Manalac
Pictured: Front view of the CDC museum in Georgia
CDC
RFK Jr. Appoints 2 New Advisors to CDC Vaccine Panel Ahead of March Meeting
One of the two new members of the CDC’s Advisory Committee on Immunization Practices questioned the safety of COVID-19 vaccines before the Texas Senate in 2021.
March 2, 2026
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2 min read
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Tristan Manalac
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Bladder cancer
Merck, Pfizer’s Drug Combo ‘Rewrites the Standard of Care’ in Bladder Cancer
A combination of Merck’s Keytruda and Pfizer’s Padcev could offer a chemotherapy-free treatment alternative for patients with muscle-invasive bladder cancer, even those eligible for cisplatin treatment.
March 2, 2026
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2 min read
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Tristan Manalac
A scientist with pill bottles in front of FDA headquarters
Regulatory
FDA Action Alert: BMS, GSK, Aldeyra and More
On the FDA’s docket this month are two decisions pushed back from 2025, including one for a rare form of obesity and another for dry eye disease.
March 2, 2026
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4 min read
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Tristan Manalac
Female hand showing thumbs up gesture on blue background, art collage. Positive hand sign. Fashion collage in the style of Thumbs up magazine. Contemporary art. Modern design.
Approvals
Boehringer Wins Speedy Lung Cancer Approval Under Commissioner’s Priority Program
Hernexeos is the second drug to secure an FDA approval under the agency’s priority voucher scheme, following in the footsteps of USAntibiotics’ Augmentin XR, which was granted the ticket in December 2025.
February 27, 2026
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2 min read
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Tristan Manalac
Finding Talented People. Big Hands with Magnifying Glass Recruiting People. vector
FDA
Prasad Under Probe for Promoting Workplace Toxicity, Staffers Say
Aside from creating a toxic work environment, CBER Director Vinay Prasad has also been accused of berating his staff and retaliating against reviewers who questioned his decisions.
February 27, 2026
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2 min read
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Tristan Manalac
FDA commissioner Marty Makary speaking on a Youtube video, wearing a dark suit and a blue tie
Regulatory
Makary Defends FDA’s Decision-Making Amid Contentious Rare Disease Rejections
Without naming a specific product, Commissioner Marty Makary referred to an investigational therapy, delivered surgically into the brain, that the FDA was “pressured” to approve even after finding no clinical benefit to patients.
February 27, 2026
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2 min read
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Tristan Manalac
Control, Complex work, Businessman balancing on a ball
Deals
Boehringer Seeks To Rebalance Immunity With Sitryx Collab Potentially Worth $500M+
While Boehringer Ingelheim hasn’t yet revealed what diseases it will go after, Sitryx’s oral drug candidate could potentially be disease-modifying for a variety of autoimmune and inflammatory conditions.
February 26, 2026
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1 min read
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Tristan Manalac
Two arrow signs representing the new way and old way approach to business
Regulatory
Atara Climbs Amid Report of FDA Inconsistency Leading to Cell Therapy’s Rejection
The rejection of Atara Biotherapeutics’ Ebvallo in January was a “complete reversal” of the conesensus FDA reviewers had come to, according to a former agency employee, who said manufacturing problems were the only approvability barrier for the drug.
February 26, 2026
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1 min read
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Tristan Manalac
Working man icon pushing the load on the line. Hard work, labor, effort and determination concept.
HIV
Gilead, Merck Clear Path to Market for Daily HIV Pills With New Late-Stage Data
At the 2026 Conference on Retroviruses and Opportunistic Infections, Gilead and Merck demonstrated that their respective daily oral HIV drugs can match current therapies in keeping the virus at bay.
February 26, 2026
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2 min read
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Tristan Manalac
change one's mind, decision, direction
Gene editing
Pfizer Advances Beam’s Gene Editor After Pulling Hemophilia Gene Therapy
Pfizer will be responsible for all global clinical and regulatory activities for Beam Therapeutics’ liver-directed gene editor.
February 26, 2026
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1 min read
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Tristan Manalac
A pill bottle in between two injector pens
Weight loss
Novo Leans Into Oral Route With Weight Loss Partnership Worth up to $2.1B
After its next-generation obesity asset CagriSema lost a head-to-head matchup with Eli Lilly’s Zepbound, Novo Nordisk is throwing more money into the obesity space, striking a deal with Vivtex to advance novel weight loss pills.
February 25, 2026
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2 min read
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Tristan Manalac
The white plane flies against the blue sky, leaving a white trail. Vector illustration
Vaccines
Postponed ACIP Meeting Rescheduled for Mid-March
The rescheduling of the Advisory Committee on Immunization Practices comes amid fresh leadership upheaval at the CDC as NIH director Jay Bhattacharya replaces Jim O’Neill as acting head of the agency.
February 25, 2026
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3 min read
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Tristan Manalac
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