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Even as FDA approvals for biologic therapies fell in the first half of 2026, regulatory experts are optimistic about a turnaround in the rare disease space after the departure of key leaders at the agency. Still, there will continue to be tension between science and politics.
FEATURED STORIES
A mostly black box since emerging with more than a billion dollars in hand, Xaira Therapeutics is slowly pulling back the curtain, revealing plans to find partners and validate its pipeline.
After debuting on the public markets with $256.3 million and raking in an additional $472 million, Veradermics has emerged as one of biotech’s biggest post-IPO standouts. CEO Reid Waldman credits the weight loss craze for establishing consumer-driven channels.
Molecular glue degraders are gaining traction in the clinic as well as funding from Big Pharma, with their potential to treat previously “undruggable” cancers and immunological diseases. Here are five clinical programs worth keeping an eye on.
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
THE LATEST
Sanofi and Novartis kick off the heart of earnings season; Lilly strikes its fourth pact in as many weeks; Regeneron earns landmark approval for a gene therapy for a type of genetic deafness, and also strikes a White House deal; FDA asks Amgen to withdraw Tavneos and, separately, issues Commissioner’s National Priority Vouches to three unnamed psychedelics companies.
Angel investors are raising the bar with tighter criteria, backing strong teams, realistic markets and clear paths to exit while applying deeper, domain-specific diligence to early stage bets.
Altitude Labs, an offshoot of AI-focused techbio Recursion, is teaching scientists to build companies, one founder at a time.
With six acquisitions already this year, Eli Lilly’s business development shows no signs of stopping as executives make good on a promise to spend their GLP-1 gains.
Staff at Salt Lake City-based techbio company Recursion recently heard from Jenny and Tim Jones about their challenging family history of familial adenomatous polyposis.
AbbVie is setting up a shot to buy Kestrel Therapeutics down the line, as the biotech doses patients in a Phase 1 trial for the oral pan-KRAS inhibitor KST-6051 in solid tumors.
Topline Phase 3 results of survodutide—licensed to Boehringer Ingelheim from Zealand Pharma—are more comparable to Novo Nordisk’s Wegovy than to Eli Lilly’s Zepbound, William Blair analysts said on Tuesday.
Cancer cocktails pairing Moderna’s mRNA-4359 with Merck’s Keytruda and Marengo’s invikafusp alfa with Gilead Sciences’ Trodelvy showed promising results, while a complex combination by Agenus and MiNK Therapeutics failed to elicit an overall response.
Weight loss giant Eli Lilly has penned a DNA editing deal with Profluent Bio, continuing its dealmaking spree as well as its commitment to artificial intelligence.
The FDA has renewed calls for Amgen’s Tavneos to be pulled from the market, saying it has discovered new evidence that study personnel doctored the results of the drug’s pivotal study in order to make it look effective.