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Acting Center for Drug Evaluation and Research Director Tracy Beth Høeg reportedly disagreed with staff who wanted to approve Sanofi’s type 1 diabetes drug. It’s far from the first time a political appointee has allegedly meddled in a recent FDA decision.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.
In Salt Lake City, biotech founders new and seasoned reflect on ways to ride out the industry’s challenges, such as sending cold emails to investors and learning to address leadership weaknesses.
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As part of an ongoing Senate investigation into pharma companies’ tax rates, Sen. Ron Wyden (D-Ore.) has asked Pfizer CEO Albert Bourla to explain irregularities in its reported revenues, losses and taxes paid.
Johnson & Johnson on Tuesday released Phase II/III results showing its monoclonal antibody Tremfya is better than its blockbuster Stelara in terms of endoscopic outcomes in Crohn’s disease.
Approaches and targets for depression and other mental health illnesses have remained stagnant for decades. With several readouts for novel therapies on the horizon, that could be changing.
Odds are, you won’t love every job. Is that OK? And what should you do if you’re struggling to find happiness at work?
Participants experienced fewer asthma attacks when receiving the antibody every six months, GSK said Tuesday, positioning the company to file for approval of the potential blockbuster.
Formerly known as AbGenomics Holding, AltruBio on Tuesday said it will use the funds to push its ulcerative colitis asset into a Phase IIb trial with an anticipated readout in 2026.
Eli Lilly is paying $60 million upfront to Aktis Oncology to discover and develop novel tumor-targeting radiopharmaceuticals, as radiopharma dealmaking continues to heat up in 2024.
The PR departments of Chinese CDMOs affected by the BIOSECURE Act and their U.S. partners must step up to ensure proposed legislation doesn’t squash innovation.
AstraZeneca on Tuesday laid out an ambitious plan to boost growth in its existing oncology, biopharma and rare disease portfolios, as well as launch 20 new medicines before the end of the decade.
Late-stage results from the NOTUS trial showed Sanofi and Regeneron’s Dupixent lowered moderate to severe chronic obstructive pulmonary disease exacerbations by 34% and led to significantly better lung function.