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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.
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Many scientists-turned-CEOs paradoxically abandon scientific principles when it comes to commercializing their innovations. But applying the scientific method to business decisions can help life science entrepreneurs avoid common pitfalls, attract investment and ultimately bring transformative technologies to market.
FDA vouchers are normally a coveted prize for biopharma companies, but a surprise rejection for Disc Medicine’s rare disease drug has biopharma reconsidering.
PitchBook’s 2025 biopharma VC analysis clocked $33.8 billion in capital dispatched in 2025, mainly to companies with later-stage programs ready to roll into the clinic.
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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.
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The BIOSECURE Act, which seeks to protect U.S. national security from Chinese biotech companies, will not be part of the House of Representatives vote on the 2025 fiscal year National Defense Authorization Act.
The FDA has a packed calendar this week, with six decisions on the docket, including ones for Merck’s Keytruda, BMS’s Krazati and Sarepta’s Elevidys.
Teva Pharmaceuticals lost its patent row with Amneal Pharmaceuticals on Monday as a New Jersey court ruled that some of Teva’s claims over its inhaler product ProAir HFA were improperly listed on the FDA’s Orange Book.
Seeking to target the lucrative obesity market, Merck is focusing its R&D efforts on next-generation GLP-1 therapies that offer additional benefits beyond weight loss, according to company executives.
Sen. Bernie Sanders (I-Vt.), chair of the Senate health committee, has proposed issuing a subpoena to Novo Nordisk President Doug Langa forcing him to testify regarding the company’s pricing for Wegovy and Ozempic.
Biogen recently bolstered its pipeline with a potential $1.8 billion acquisition of Human Immunology Biosciences, following other big players looking to cash in on a global immunology market estimated to grow to $257 billion by 2032.
This week, an FDA adcomm unanimously voted for the approval of Eli Lilly’s anti-amyloid antibody as thousands of layoffs continue to rattle the industry.
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Stada announced Tuesday it has secured European rights from Alvotech to a clinical-stage biosimilar of Amgen’s blockbuster bone drugs Prolia and Xgeva.
While Sage Therapeutics’ drug candidate showed a slight difference compared to placebo in a mid-stage Huntington’s disease trial, William Blair analysts in a Tuesday note to investors said they “remain cautious” on dalzanemdor and “do not view the small numerical changes as definitive.”