BioSpace News Archive

Illustration showing a downward graph trend

Regulatory

Future of Aardvark’s Prader-Willi drug in doubt as FDA slaps full hold on program

Aardvark Therapeutics had previously voluntarily suspended studies of ARD-101—and a related asset called ARD-201—after detecting anomalous echocardiographic readings in healthy volunteers that could indicate reduced heart efficiency.

May 15, 2026

·

2 min read

·

Tristan Manalac

Save money and investment concept. Closeup piggy bank and silver coins falling. 3d rendering illustration

Series B

CREATE jumps into CAR T competition with $122M series B

CREATE Medicines is working on a clinical-stage pipeline for cancer, while its autoimmune programs are still in preclinical testing.

May 15, 2026

·

2 min read

·

Tristan Manalac

Manufacturing

Sun Pharma recalls cancer drug after finding glass particles in some vials

A batch of a chemotherapy product made at a Sun facility with a history of quality and compliance issues is being withdrawn from the U.S. market.

May 15, 2026

·

2 min read

·

Nick Paul Taylor

Brain shaped maze. Conceptual image of science and medicine. 3D illustration.

Drug Development

Biogen’s Alzheimer’s results bolster tau theory—and Denali’s next gen candidate

If Biogen has shown that tau can impact cognition, Denali’s technology—validated with an FDA approval in Hunter syndrome—could ensure the medicine gets where it needs to be for the greatest therapeutic impact, analysts said.

May 15, 2026

·

3 min read

·

Annalee Armstrong

Sorting garbage concept. Cropped photo of paper thash. Crumple paper falling to the recycling bin

Drug Development

Genmab drops 2 antibody assets, including another ProfoundBio ADC

Rina-S is the last candidate standing from Genmab’s $1.8 billion ProfoundBio acquisition two years ago, with the Danish drugmaker ending development of another clinical program stemming from the buyout.

May 15, 2026

·

2 min read

·

Gabrielle Masson

Image of San Francisco from San Francisco Headlands

Job Trends

Employment and funding growth fell in 2025: California Life Sciences report

California life sciences jobs declined 1.8% last year, according to the new California Life Sciences sector report. While National Institutes of Health funding and venture capital investment rose, their growth slowed from the previous year.

May 15, 2026

·

2 min read

·

Angela Gabriel

Illustration of young woman standing in front of exit door

FDA

Interim CDER head Høeg is out days after Makary: report

Just a few days after FDA Commissioner Makary resigned, ally Tracy Beth Høeg is also leaving the agency. Her departure comes amid reports of tension over a commissioner’s voucher for Sanofi’s diabetes drug.

May 15, 2026

·

2 min read

·

Gabrielle Masson

Press Releases

Phase II Data from a Randomized Double-Blind Trial of Ligufalimab (Anti-CD47) Combination Therapy in Frontline AML Published at EHA 2026

May 15, 2026

·

5 min read

Press Releases

Positive Interim Data from Cohorts 1 and 2 of Tenaya’s RIDGE™-1 Phase 1b/2 Clinical Trial of TN-401 Demonstrated Consistent Reductions in Arrhythmia Burden for Adults with PKP2-associated ARVC