The Latest
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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 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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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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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 roundupPfizer 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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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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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.
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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 -
Alamy
Pierre Fabre seeks to revive US approval chances for spurned cell therapy
Ebvallo is one of a series of rare disease treatments recently turned back by the FDA amid shifting guidance that has surprised some companies and frustrated investors.
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Permission granted by Candid Therapeutics
Candid, in a reverse merger with RallyBio, to go public
Candid, which is making bispecifics for immune diseases, has also raised $505 million in a private financing for the newly formed company.
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UniQure says FDA wants another study of Huntington’s gene therapy
Agency staff "strongly recommended" a sham surgery-controlled trial be conducted before an approval filing, a stance one analyst called a "worst case scenario" for UniQure.
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News roundup
FDA again targets GLP-1 compounders; Intellia to restart heart disease trial
The agency zeroed in on claims that compounded GLP-1 drugs are comparable to approved medicines. Elsewhere, a blood pressure drug topped Wall Street expectations and a Merck deal paid dividends.
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Bhagavatheeshwaran, Govind. (2016). "MRI Scan" [Image]. Retrieved from Flickr.
Roche pill succeeds in another MS study, but approval questions linger
Liver-related side effects have led some analysts to question fenebrutinib’s prospects, even though the drug has now cleared Phase 3 studies in multiple forms of the disease.
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Safety concerns spur Aardvark to halt key Prader-Willi drug trial
The detection of certain cardiac issues in a study of healthy volunteers led Aardvark to pause a Phase 3 trial only months before an expected data readout.
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Ascendis wins FDA approval of dwarfism drug
Yuviwel, a once-weekly injection, will now compete for market share with BioMarin’s lucrative daily shot Voxzogo.
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UniQure falls further on Makary comments
Remarks the FDA commissioner made during a CNBC appearance seemed to stoke investor fears that UniQure's gene therapy for Huntington's won't get approved.
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Startup launchesAtrium spins out of Avidity, aiming to target rare heart diseases with RNA
Four months after Avidity’s $12 billion buyout, Atrium debuted with $270 million in cash and plans to pick up its predecessor’s work in cardiovascular disease.
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IPO windowGenerate caps a strong month for biotech IPOs with $400M offering
The AI drug discovery specialist is the fifth biotechnology company to go public in February and priced the sector’s largest new stock offering in nearly three years.
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Courtesy of Sarepta
Sarepta CEO Doug Ingram to retire, with company at a crossroads
Ingram, who steered the company through multiple drug approvals and controversies, will step aside as Sarepta faces dwindling Elevidys sales and emerging competitors to its core business.
