Even Early Stage Biotechs Can’t Ignore Tariffs
Early decisions about manufacturing and supply chains could prove costly as a company reaches the commercial stage.
Richard Pazdur, FDA drug czar, to retire from agency
Weeks after being named head of CDER, Pazdur has submitted paperwork to step down at the end of the month, exacerbating what’s already been a turbulent year at the FDA.
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Richard Pazdur, FDA drug czar, to retire from agency
Weeks after being named head of CDER, Pazdur has submitted paperwork to step down at the end of the month, exacerbating what’s already been a turbulent year at the FDA.
Richard Pazdur, FDA drug czar, to retire from agency Read More »
Pazdur To Retire Weeks After Taking On Coveted FDA Role
Newly appointed Center for Drug Evaluation and Research director Richard Pazdur has filed retirement papers with the agency—three weeks after accepting the role—amid clashes with Commissioner Marty Makary over certain FDA programs.
Pazdur To Retire Weeks After Taking On Coveted FDA Role Read More »
FDA flags risk from dropped BD Alaris pumps after 2 injury reports
BD told customers to immediately remove from use any devices they drop or severely jar.
FDA flags risk from dropped BD Alaris pumps after 2 injury reports Read More »
Imvax Heads to FDA With 6-Month Survival Gain in Glioblastoma, Despite Endpoint Miss
While Imvax’s autologous immunotherapy IGV-001 missed the primary endpoint of progression-free survival in a Phase IIb trial, the company will request a meeting with the FDA to discuss next steps for “synergistic” treatment.
Imvax Heads to FDA With 6-Month Survival Gain in Glioblastoma, Despite Endpoint Miss Read More »
Cleveland Diagnostics wins FDA nod for prostate cancer test
The IsoPSA test is intended to help assess whether patients with elevated PSA levels should go on to receive a biopsy procedure.
Cleveland Diagnostics wins FDA nod for prostate cancer test Read More »
Experts Decry Prasad Memo’s Lack of Transparency as Vaccine Stocks Dip
With no evidence to support the claim that 10 children died due to COVID-19 vaccines, experts unpack the impact of CBER chief Vinay Prasad’s leaked vaccine memo.
Experts Decry Prasad Memo’s Lack of Transparency as Vaccine Stocks Dip Read More »
Family physicians are departing rural areas: report
Between 2017 and 2023, the share of family physicians working in rural areas dropped 11%, according to a study published in the Annals of Family Medicine.
Family physicians are departing rural areas: report Read More »
I Remember Aduhelm. The Return of Roche in Alzheimer’s Is a Turning Point
After covering the Alzheimer’s space through every high and low, BioSpace’s Annalee Armstrong welcomes back Roche for the 2026 Alzheimer’s Renaissance.
I Remember Aduhelm. The Return of Roche in Alzheimer’s Is a Turning Point Read More »