The Latest
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Kendall Davis/BioPharma Dive
Tracker10 clinical trials to watch in the first half of 2026
After a lengthy downturn, the biotech industry finally gathered momentum in 2025. Key readouts in obesity, infectious disease and many rare conditions could help it continue.
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Permission granted by MilliporeSigma
Sponsored by MilliporeSigmaNavigating the PPQ process: Proven strategies to safeguard quality for cell and gene therapies
An often overlooked but critically important step along the path from bench to bedside, PPQ often results in delays and potential non-compliance issues without proper planning.
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Permission granted by Vertex Pharmaceuticals
Vertex kidney disease drug hits mark in late-stage study
Company shares surged in after-market trading on results for a drug Vertex acquired in a multibillion-dollar deal and sees as having “best-in-class potential” in a competitive field.
Updated March 10, 2026 -
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Bristol Myers claims success in study of another next-gen blood cancer drug
The therapy, mezigdomide, is part of group of medicines the pharma sees as successors to its lucrative multiple myeloma drugs Revlimid and Pomalyst.
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Courtesy of CSL
CSL breaks ground on $1.5B Illinois immunoglobulin plant expansion
The Kanakee project builds on the company’s efforts to increase its U.S. footprint, where it has already spent more than $3 billion, and will focus on producing plasma-derived therapies.
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Adeline Kon/BioPharma Dive
Deep Dive // IPO windowBiotech IPOs are the industry’s lifeblood. Track how they’re performing.
Oncology drugmaker Salspera has set terms for a public offering that could net up to $91 million to support a late-stage study of its lead program saltikva in pancreatic cancer, according to a Tuesday securities filing.
Updated 4 hours ago -
Retrieved from FDA.
Trump administrationVinay Prasad, controversial FDA leader, to again depart agency
Prasad’s planned departure, expected at the end of April, culminates a tumultuous term in which he reworked vaccine guidelines and was criticized for his office’s stance on several rare disease drugs.
Updated March 7, 2026 -
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News roundupXenon hits a ‘home run’ in epilepsy; FDA restarts review of Duchenne cell therapy
Xenon shares skyrocketed nearly 50% on results that handily beat Wall Street expectations. Elsewhere, Capricor got a decision date for a spurned cell therapy and AbbVie and Regeneron showcased obesity data.
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Roche’s prized breast cancer pill fails closely watched study
The result “pulls the rug” out from under giredestrant, according to one analyst, sparking another share selloff following disappointing obesity data last week.
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Adeline Kon/BioPharma Dive
Deep DiveBiotech M&A is accelerating. Track the deals that are happening here.
Servier’s buyout of Day One is the year’s second-largest biotech acquisition so far, trailing only Gilead’s $7.8 billion purchase of cell therapy maker Arcellx.
Updated March 6, 2026 -
Courtesy of Hims & Hers
Obesity drugsNovo, Hims reach deal to sell GLP-1 drugs together
The agreement ends a messy dispute that began when the telehealth firm attempted to sell a compounded form of Novo’s Wegovy pill at a cheaper price.
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Courtesy of Ipsen
Ipsen to withdraw cancer drug acquired in buyout due to safety concerns
Ipsen found cases of secondary malignancies in a confirmatory study of Tavzerik, a medicine it got in a purchase of Epizyme and that it has struggled to sell.
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Servier to build cancer drug pipeline with $2.5B purchase of Day One
The proposed acquisition would hand Servier a couple experimental drugs in human testing as well as Ojemda, an approved therapy for certain hard-to-treat brain tumors that affect children.
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China competitionDrugs from China are reshaping biotech. Track the licensing deals here.
Sanofi reached a deal for rights to a drug already on the market in China, while UCB is the latest to bet on the ability of T cell engagers to treat autoimmune conditions.
Updated March 4, 2026 -
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FDA issues speedy approval to J&J’s Tecvayli-Darzalex combo
The regimen’s clearance in early multiple myeloma was the third approval under the agency’s controversial “national priority” voucher program and issued only 55 days after the review began.
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Permission granted by Roche
Obesity drugsRoche, Zealand shares fall on ‘undifferentiated’ obesity drug results
An amylin-targeting medicine at the center of the companies’ multibillion-dollar alliance spurred less weight loss than investors had hoped, leading some analysts to question its ability to stand out.
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Obesity drugsLilly targets employers in new bid to broaden access to obesity drugs
A service tailored to people with workplace-based insurance coverage represents a new way for Lilly to bypass insurers and expand use of its popular obesity shot.
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Adeline Kon/BioPharma Dive/BioPharma Dive
Deep Dive // Emerging biotechBiotech startups are built on venture capital. Track funding rounds here.
RA Capital has been the most active investor so far this year among the firms tracked by BioPharma Dive, participating in 10 funding rounds in total and three in the last week alone.
Updated March 9, 2026 -
Courtesy of Teva Pharmaceutical
Blackstone puts $400M into Teva, Sanofi gut disease drug
The deal adds to a growing biotech presence for Blackstone and supports testing of a drug competing with rival therapies from Merck and Roche.
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News roundup
Pfizer nabs first obesity approval; Alnylam, Tenaya search for heart drugs
The clearance in China comes weeks after Pfizer acquired rights to the therapy. Elsewhere, Alnylam is looking for “novel” cardiovascular targets and investors sold off Helus shares.
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Emerging biotechA startup making drugs for blood disorders banks $160M
Atavistik Bio is using the cash to develop “allosteric” medicines it believes can precisely impact on diseases like myelofibrosis and the blood condition HHT.
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Alamy
PepGen muscular dystrophy drug gets ‘surprise’ hold from FDA
The agency acted after reviewing mouse data submitted in 2024, making the timing of the new pause “confusing,” one analyst wrote.
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Maddie Meyer via Getty Images
VaccinesModerna to pay up to $2.25B to end mRNA vaccine patent fight
Announced days before a trial, the deal settles a longstanding dispute and avoids what one analyst called a “worst-case scenario” financially for Moderna.
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Gene editingPrime to test FDA flexibility with 2-patient gene editing submission
The planned filing comes amid heightened scrutiny of the FDA’s rare disease stance and a year after Prime deprioritized the program for economic reasons.
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Alamy
Trump administration
5 FDA decisions to watch in the first quarter of 2026
By the end of March, the agency could approve multiple “national priority” voucher winners, as well as a gene therapy it rejected two years ago.
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Courtesy of Kyowa Kirin
Kyowa Kirin abandons touted eczema drug following safety review
A month after Amgen gave up on rocatinlimab — which was once seen as a threat to Dupixent — new findings have linked the drug’s mechanism to the onset of a type of skin cancer.
