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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.

Pictured: gene editing on DNA Background / Taylor
gene editing
Gene therapy leaders aim to help more Baby KJs with novel regulatory models
As cell and gene therapy leaders gathered in Maryland to discuss accelerating clinical trials in children, one “cutting edge” session focused on the need to expedite more bespoke gene editing treatments like the one that saved young KJ Muldoon.
April 27, 2026
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5 min read
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Heather McKenzie
Psychedelic Brain
Psychedelics
FDA awards priority vouchers to 3 undisclosed companies for investigational psychedelics
While the FDA did not announce the recipient names of the Commissioner’s National Priority Vouchers, the agency’s descriptions of the awarded products match those in development at Compass Pathways, Transcend Therapeutics and Usona Institute.
April 24, 2026
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3 min read
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Heather McKenzie
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Gene therapy
FDA approval of Regeneron’s hearing loss gene therapy breaks barriers
Approved Thursday via the FDA’s Commissioner’s National Priority Voucher program, Otarmeni is the first gene therapy for hearing loss—and the first treatment to target an underlying cause of the condition.
April 23, 2026
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4 min read
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Heather McKenzie
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Psychedelics
Trump’s psychedelics push a mixed blessing for neuropsychiatric companies, patients
With a greenlight for ibogaine to enter clinical testing and three unnamed products set to receive Commissioner’s National Priority Vouchers this week, it’s full speed ahead for psychedelics. But will sidestepping normal regulatory protocols actually be a net negative for the field?
April 22, 2026
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8 min read
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Heather McKenzie
Podcast
Trump’s psychedelics push, Lilly’s up to $7B CAR T deal, Replimune’s saga and Denali’s big win
The deals keep rolling in, with Lilly penning a $7 billion pact for gene delivery biotech Kelonia Therapeutics and UCB taking over cell therapy-focused Neurona Therapeutics; President Trump signed a new executive order supporting the development of psychedelic therapies, sparking fanfare and concern alike; and the FDA’s recent Replimune decision has triggered broader debate about the agency’s flexibility.
April 22, 2026
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1 min read
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Heather McKenzie
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FDA
Replimune cries foul on regulatory flexibility. But many Americans want a stricter FDA
After Replimune’s advanced melanoma drug was rejected for a second time, CEO Sushil Patel slammed the FDA for failing to exercise regulatory flexibility, while other experts bemoaned the agency’s lack of consistency. With new safety guidelines for gene editing therapies, the FDA has taken a first step toward fixing both problems.
April 17, 2026
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5 min read
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Heather McKenzie
Pictured: CDC signage at its headquarters in Georg
CDC
Trump nominates new CDC director, appoints various leaders to embattled agency
Erica Schwartz, a former deputy surgeon general and member of the U.S. military, will take over from what has amounted to a rapid succession of CDC leaders over the past year.
April 16, 2026
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2 min read
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Heather McKenzie
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FDA
Drug pricing watchdog calls for increased transparency into FDA’s accelerated approval decisions
Greater transparency in FDA decision-making was possibly the most common theme for stakeholders interviewed by the Institute for Clinical and Economic Review in a new report focused on strengthening the agency’s accelerated approval program.
April 16, 2026
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4 min read
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Heather McKenzie
Podcast
J&J targets $100B revenue, Replimune rebuffed again and a “Revolution” in pancreatic cancer
Johnson and Johnson kicked off first-quarter earnings season with a “modest” beat and an ambitious goal; Replimune failed again to gain approval for its advanced melanoma therapy, as analysts tout increased accountability brought by the FDA’s new policy of publicizing complete response letters; and Revolution Medicines’ pancreatic cancer candidate doubled survival in one of cancer’s most intractable foes.
April 15, 2026
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1 min read
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Heather McKenzie
FDA
Deep dive: Checking in with the FDA
BioSpace looks back at 2025 and where the FDA is going in 2026.
April 15, 2026
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2 min read
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Heather McKenzie
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Earnings
With nearly a quarter billion in Q1, J&J targets $100B revenue in 2026
With robust sales performance from oncology darling Darzalex and immunology superstar Tremfya, Johnson & Johnson is “off to a fast start in 2026,” CEO Joaquin Duato told investors on Tuesday.
April 14, 2026
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3 min read
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Heather McKenzie
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Cancer
IDEAYA and Servier’s eye cancer drug heads to FDA after delivering ‘best in class’ efficacy
Darovasertib, in combination with crizotinib, more than doubled progression-free survival in a registrational trial, leading Truist analysts to declare a “best-in-class efficacy profile” for the PKC inhibitor.
April 13, 2026
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2 min read
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Heather McKenzie
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Regulatory
FDA flexibility isn’t absent but evolving regulations come with growing pains
The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare diseases. Executives at Rezolute and CERo Therapeutics recently had positive interactions with the agency, in which they told BioSpace reviewers have been “collaborative” and “curious.
April 13, 2026
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5 min read
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Heather McKenzie
A person and a group of people are separated by a yellow line. Establishing contact. Distrust. Quarantine. Distance with strangers. Barrier to understanding, difficult integration. Rejection, refusal.
Complete response letters
Replimune’s advanced melanoma drug rebuffed by FDA for second time
The FDA in a complete response letter to Replimune maintained its original objection to the single-arm trial the biotech used to support the application for RP1.
April 10, 2026
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2 min read
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Heather McKenzie
Podcast
Lilly’s Foundayo Nod Launches New Battle With Novo, M&A Mania Continues, Tariffs Hit Pharma
The approval of Eli Lilly’s oral obesity drug officially ignites an intense competition with Novo Nordisk’s oral Wegovy; Gilead Sciences and Neurocrine Biosciences keep the M&A train chugging; Trump hits pharma with his long promised tariffs, and the FDA proposes many changes with 2027 budget.
April 8, 2026
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1 min read
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Heather McKenzie
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