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Heather McKenzie

Heather McKenzie

Senior Editor

Heather McKenzie is a professional journalist with more than five years experience in the biopharmaceutical industry. Since joining BioSpace, she has written more than 200 features and breaking news articles with a particular focus in neuroscience and gene therapy. She has also traveled internationally to cover global biotech hubs such as 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, 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.

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Sickle cell disease
Sickle Cell Gene Therapies Casgevy and Lyfgenia Still Lacking Traction 2 Years In
The first gene therapies approved to treat sickle cell disease in December 2023 are struggling on the market. But there are glimpses of forward momentum as Vertex and Genetix Bio provide updates.
February 23, 2026
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6 min read
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Heather McKenzie
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FDA
Makary, Prasad Under Fire as FDA Turmoil Reaches President Trump
Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.
February 20, 2026
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6 min read
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Heather McKenzie
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).
FDA
FDA Reverses Course on Moderna’s mRNA Flu Shot Application, Promising August Decision
The disagreement between Moderna and the FDA has reached a resolution just eight days after the biotech received a Refusal-to-File letter in response to its application for mRNA-1010. Moderna will now seek approval of the vaccine based on age.
February 18, 2026
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3 min read
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Heather McKenzie
Podcast
Modernagate Fallout, Disc’s Rejection, Compass’ Psilocybin Data, CDC’s Lost Leaders
The FDA outright refuses to review Moderna’s mRNA-based flu vaccine as CBER director Vinay Prasad’s conduct is scrutinized; Disc Medicine receives an unexpected rejection, which Prasad may also have had a hand in; Compass Pathways posts new late-stage data on its psilocybin-based depression drug; CDC is once again leaderless.
February 18, 2026
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1 min read
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Heather McKenzie
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Psychedelics
Compass’ Psychedelic Shows Durability ‘In Spades’ as Path to FDA Clears
Evidence of durability of psilocybin-based COMP360 is a key point for the FDA, according to Compass Pathways Chief Medical Officer Guy Goodwin. By providing 26 weeks’ worth of such data instead of the requested 12, the company is delivering “in spades,” he said.
February 17, 2026
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3 min read
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Heather McKenzie
stethoscope on glass globe - Usa
FDA
Moderna’s mRNA Vaccine Refusal Comes Amid Global Advanced Therapies Push
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is “part of a disturbing pattern” of moving regulatory goalposts, according to Clay Alspach, executive director of the Alliance for mRNA Medicines. Meanwhile, streamlined communications with regulators in other countries pave the way for rapid uptake of novel modalities.
February 17, 2026
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5 min read
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Heather McKenzie
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FDA
Moderna’s Outright Flu Refusal Just the Latest Case of Crossed FDA Signals
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
February 13, 2026
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6 min read
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Heather McKenzie
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Gene therapy
In Vivo Is Having a Moment as Cell and Gene Therapy Sector Gathers in San Diego
A recurring theme Tuesday morning at Phacilitate’s Advanced Therapies Week was the quickly emerging potential of in vivo approaches to cell and gene therapy—a trend also reflected in recent investments by Eli Lilly and Regeneron.
February 11, 2026
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4 min read
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Heather McKenzie
Digital compass. Business strategic explorer, Vision crisis, Mission path, Agency creative, Digital strategy, Market decision, Achievement strategy, Financial stock, Company vision concepts
Policy
FDA Policy Tracker 2026: Priority Vouchers Questioned, PRVs Return
A year of significant policy change at the FDA brought momentum and scrutiny into the new year. As 2026 gets underway, biopharma companies are responding to sweeping vaccine changes while concerns surface about the politicization of the agency.
February 9, 2026
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5 min read
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Heather McKenzie
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Duchenne muscular dystrophy
Following Sarepta Woes, Others Look To Unlock the Next Chapter in DMD Treatment
With a clutch of key data and planned regulatory applications this year from Avidity Biosciences, REGENXBIO and Capricor Therapeutics, CureDuchenne CSO Michael Kelly sees “momentum” in the Duchenne muscular dystrophy pipeline, as Sarepta’s Elevidys leaves the door open.
February 9, 2026
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11 min read
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Heather McKenzie
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Immunology and inflammation
Lilly Eyes Pipeline in a Product as GLP-1s Move Into I&I
In addition to claiming revenue of $19.3 billion for the fourth quarter, Eli Lilly executives offered a glimpse into their strategy to expand their GLP-1 franchise into the immunology and inflammation space, with trials currently underway in asthma, psoriatic arthritis, Crohn’s disease and ulcerative colitis.
February 4, 2026
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2 min read
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Heather McKenzie
Podcast
Pfizer’s Metsera Data, 2025 Earnings, the FDA and REGENXBIO, Psychedelics and IPOs
Pfizer announces the first data from its Metsera-acquired pipeline just ahead of its earnings call, where analysts pressed execs for more details; Merck and Roche also released Q4 and full year earnings, with Eli Lilly, Novo Nordisk and others reporting Wednesday; REGENXBIO hits a regulatory snag ahead of its upcoming PDUFA; more.
February 4, 2026
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1 min read
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Heather McKenzie
External view of the U.S. Capitol building at sunset
Rare diseases
Rare Pediatric Disease Vouchers Reauthorized, PBM Reform Funded in Narrowly Passed Spending Bill
U.S. President Donald Trump signed a spending package into law Tuesday that reauthorizes the FDA’s previously stalled rare pediatric disease priority review voucher program, among other initiatives, while ending a three-day partial government shutdown.
February 3, 2026
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3 min read
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Heather McKenzie
This 3D rendering encapsulates the concept of a winning strategy in business, emphasizing productivity, innovation, and the importance of female leadership. The imagery represents the synergy of teamwork, where diverse ideas and collaborative efforts drive success and growth. It highlights the critical role of women in leadership positions, showcasing their contributions to strategic planning and innovation. This visual serves as an inspiring representation of how inclusive leadership and innovative thinking can propel a business toward achieving its goals and maintaining a competitive edge in the market.
Wave To Work Alone on RNA Editor as AATD Picture Becomes Clearer
After GSK’s return of Wave Life Sciences’ WVE-006 as well as the mid-stage failure of Korro Bio’s candidate, the alpha-1 antitrypsin deficiency landscape is coming into focus, with Wave and Beam Therapeutics leading the way.
February 2, 2026
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3 min read
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Heather McKenzie
Creative concept of Left and right brain illustration with colorful on right side isolated on dark background
Psychedelics
Psychedelics Space at a ‘Tipping Point’ as Compass, Definium Gear Up To File for Approval
With Lykos’ regulatory failure now squarely in the rearview mirror, Compass Pathways and Definium are leading what one analyst suspects will be “a very big year for psychedelics.”
February 2, 2026
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7 min read
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Heather McKenzie
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