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Heather McKenzie

Heather McKenzie

Senior Editor

Heather McKenzie is a professional journalist with more than 8 years’ experience in the biopharmaceutical industry. Since joining BioSpace, she has written more than 300 features and breaking news articles, including multiple award-winning stories. Her particular focuses are neuroscience, rare disease and regulatory science. She has also traveled internationally to cover global biotech hubs, including Israel. In previous roles, she has covered current affairs, sports, education and politics. She previously spent eight years as a senior content producer for executive-level business conferences in the pharma/biotech, legal, energy and business strategy sectors. In her free time, Heather enjoys creative writing, watching her American League champion Toronto Blue Jays, spending time with family and playing with her energetic Russian Blue cat Roofus. She hails from Toronto and has also lived in Chicago and Chesapeake, Virginia. You can reach her at heather.mckenzie@biospace.com.

Obesity
Deep dive: The oral obesity wars
BioSpace examines how the FDA approval of Eli Lilly’s oral obesity drug Foundayo has ignited a key race with Novo Nordisk.
May 18, 2026
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3 min read
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Heather McKenzie
3D. rocket soaring. Different rockets fly high and stand out. different from others, concept startup idea, new generation, faster work better
Drug Development
Is Revolution ‘the next oncology titan’? Truist analysts make the case
A month after reporting that its RAS inhibitor daraxonrasib doubled survival in advanced pancreatic cancer, Truist said Revolution Medicines “is evolving into a major revenue-generating oncology company,” and projects an approval in second-line disease by the end of the third quarter.
May 18, 2026
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3 min read
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Heather McKenzie
Stairs in sky With Light
Pancreatic cancer
Can Revolution’s ‘miracle’ pancreatic cancer drug be topped? Immuneering, Actuate say yes
Last month, Revolution Medicines’ RAS inhibitor doubled survival in a Phase 3 pancreatic cancer trial. On the biotech’s heels are Immuneering, Actuate Therapeutics, Erasca and more, looking to improve on that result with increased tolerability—and more time for patients.
May 18, 2026
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7 min read
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Heather McKenzie
Aerial view from window plane of San Cristobal at Galapagos island, Ecuador
Earnings
Goodbye Galapagos: chameleon company exits the island, rebrands as Lakefront
After a 12-month period that saw the Belgian biotech consider a spinout, swap out CEOs, and enter a three-way acquisition agreement involving Ouro Medicines, Galapagos now has a new moniker.
May 13, 2026
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2 min read
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Heather McKenzie
FDA
Makary’s out at FDA, Sanofi’s priority voucher issues, top exec pay
It’s official: FDA Commissioner Marty Makary is out at the FDA after reports of his ouster emerged late last week; Sanofi is reportedly having challenges with one of the FDA’s new signature programs; and biopharma CEOs’ multimillion-dollar salaries ticked up again this year. Who made the most in 2025?
May 13, 2026
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1 min read
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Heather McKenzie
FDA commissioner Marty Makary speaking on a Youtube video, wearing a dark suit and a blue tie
FDA
FDA’s Makary to resign after Secretary Kennedy signs off
FDA Commissioner Marty Makary intends to resign on Tuesday, according to several sources. This report follows a tumultuous 13-month tenure in which Makary oversaw the controversial rejections of several rare disease drugs and “predictable volatility” within the agency.
May 12, 2026
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4 min read
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Annalee Armstrong
The white plane flies against the blue sky, leaving a white trail. Vector illustration
FDA
FDA reverses course on Atara, Pierre Fabre’s twice-rejected cell therapy after Prasad’s exit
The FDA turned away Ebvallo in January, taking issue with the design of the registrational trial. In a recent meeting, however, the agency agreed that the study could in fact support the cell therapy’s approval. The news comes a week after the departure of controversial biologics Director Vinay Prasad.
May 7, 2026
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3 min read
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Heather McKenzie
Businessman confuse others with jargon in speech bubble dialogue
FDA
Sanofi requests removal of Tzield from CNPV program after Høeg gets involved
Acting Center for Drug Evaluation and Research Director Tracy Beth Høeg reportedly disagreed with staff who wanted to approve Sanofi’s type 1 diabetes drug. It’s far from the first time a political appointee has allegedly meddled in a recent FDA decision.
May 7, 2026
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4 min read
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Heather McKenzie
FDA
Unforced errors flummox HHS’ radical transparency bid—again
Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.
May 6, 2026
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6 min read
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Heather McKenzie
Podcast
Pfizer, Lilly, more report Q1, FDA names acting CBER director and an ALS awakening
First quarter earnings continue to arrive, with analysts demanding more from cautious Pfizer and Eli Lilly expecting more revenue; the FDA taps Katherine Szarama as Vinay Prasad’s controversial FDA tenure ends; oncology veterans miss Richard Pazdur at the agency’s first adcomm in nine months; and QurAlis and Corcept Therapeutics spark renewed hope in ALS.
May 6, 2026
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1 min read
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Heather McKenzie
Abstract blue and purple DNA molecule helix and brain. Genetic biotechnology engineering concept. Low poly style design. Geometric background. Wireframe light graphic connection structure. Vector
ALS
QurAlis’ Phase 2 data bolster case for genetic approach to sporadic ALS
Biogen’s Qalsody won FDA approval in 2023 to treat a rare, genetic form of amyotrophic lateral sclerosis. On Tuesday, QurAlis presented interim Phase 2 data showing the potential of a similar drug to more broadly treat the neurodegenerative disease.
May 5, 2026
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4 min read
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Heather McKenzie
Colorful light bulb exploding glass flying everywhere black background
Earnings
Sarepta, Amylyx and Neumora look ahead to key catalysts as Q1 earnings roll in
As Q1 earnings arrive, three biotechs have big quarters ahead, with two—Amylyx and Neumora Therapeutics—betting at least partly on novel assets for obesity.
May 5, 2026
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5 min read
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Heather McKenzie
Silver Spring, MD, USA 11/10/2020: Exterior view of the headquarters of US Food and Drug Administration (FDA). This federal agency approves medications, vaccines and food additives for human use.
FDA
FDA taps Szarama as acting CBER director as Prasad’s tumultuous tenure ends
Katherine Szarama, who has served as Prasad’s deputy at the Center for Biologics Evaluation and Research since December, joins a long list of temporary leaders at the Department of Health and Human Services.
May 1, 2026
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2 min read
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Heather McKenzie
Emblem design for airlines, airplane tickets, travel agencies. Airplane icon and destination arrow. Flags of the USA and Great Britain. 3D rendering
Huntington’s disease
UniQure eyes UK approval for embattled Huntington’s gene therapy after FDA quarrel
UniQure plans to submit AMT-130 to the U.K.’s Medicines and Healthcare products Regulatory Agency in the third quarter of 2026 based on Phase 1/2 data showing a 75% slowing of disease—the same data the FDA has deemed unacceptable for a biologics license application.
April 30, 2026
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2 min read
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Heather McKenzie
Stones in calm water with evening sun
Earnings
Regeneron basks in first gene therapy approval as Dupixent, Eylea carry robust Q1 earnings
Regeneron hauled in $3.6 billion during the first quarter of 2026, as analysts homed in on a slight Eylea HD miss and key upcoming readouts, including for LAG3 candidate fianlimab in metastatic melanoma.
April 29, 2026
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3 min read
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Heather McKenzie
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