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Drug sponsors should nevertheless bolster their application with “confirmative evidence,” chief regulators Marty Makary and Vinay Prasad said on Wednesday, including mechanistic data or findings from related indications or animal models.
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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.
Long an R&D company that partnered off assets, RNAi biotech Ionis Pharmaceuticals shifted in 2025 to bring two medicines to market alone. Analysts are already impressed—and there’s more to come in 2026.
Regulatory uncertainty is no longer background noise. It is a material investment risk that reshapes how capital is deployed and pipelines are prioritized.
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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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Fresh off its $13-billion acquisition of medical devices developer Shockwave Medical, Johnson & Johnson is expecting greater business growth in the future.
As the DOJ and SEC look into two of its senior employees, Cassava Sciences’ CEO and one senior vice president have departed the company.
The last few months have been difficult for Gilead, with several late-stage failures and development discontinuations. Amid these problems, Merdad Parsey will be stepping down from his CMO role early next year.
Looking for a biotech job in San Diego? Check out these seven top companies hiring life sciences professionals like you.
Learn five ways to answer difficult interview questions so you can leave the best impression possible on your potential employer.
Three executives whose combined careers include working at companies including Amgen, AstraZeneca, The Janssen Pharmaceutical Companies of Johnson & Johnson, Pfizer and Takeda share their career journeys.
After completing a buyout transaction with The Column Group to remove it from the stock exchange, NGM Bio has raised a $122M Series A to fund a registrational study for a rare liver disease drug and a Phase II trial in hyperemesis gravidarum.
Mid-stage data for 4D Molecular Therapeutics’ wet AMD drug 4D-150 show improvements in visual acuity, reduced injection rate and encouraging safety data.
After nixing a twice-daily version of its oral GLP-1 agonist, Pfizer is hoping to break into the weight-loss space with a once-daily version, but experts question its outlook.
As the yearslong litigation over ownership of CRISPR gene editing continues, investors have forged ahead with funding the technology’s development by biopharma.