BioSpace News Archive

Human brain with abstract visualization of neuron activity

FDA Official Fires Back at UniQure, Doubles Down on Sham-Controlled Trial

UniQure does not have to drill placebo burr holes in the skulls of patients with Huntington’s disease, an unnamed FDA senior official said on Thursday. Instead, the company would anesthetize them and put “one to three nicks” in their scalp.

March 6, 2026

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2 min read

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Tristan Manalac

Recession, reduced revenue or lower profits, gold coins roll down following the falling arrow stock illustration

Weight loss

Roche, Zealand’s Amylin Weight Loss Drug Fails To Clear Lilly’s Bar

Zealand Pharma’s shares fell 32% in early morning trading Friday after its Roche-partnered asset petrelintide failed to meet investor expectations in a mid-stage clinical trial.

March 6, 2026

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3 min read

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Tristan Manalac

Pictured: Johnson & Johnson Business Center in Switzerland

Immuno-oncology

J&J Wins Third National Priority Approval for Multiple Myeloma Combo

The FDA granted Johnson & Johnson a Commissioner’s National Priority Voucher in December 2025 after the combination of Darzalex and Tecvayli improved progression-free survival by 83%. The new approval is for second-line treatment of the blood cancer.

March 6, 2026

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2 min read

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Tristan Manalac

pills with dollar sign isolated on white background

Opinion

Direct-to-Consumer Drugs Are Not a Panacea for High Costs

TrumpRX and DTC sales may expand prescription drug access, but they will not solve the affordability crisis by themselves.

March 6, 2026

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4 min read

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Michael Grosberg

Brain tumor medical poster. Cancer, metastasis or benign in the human head or in the nerves, pituitary gland, pineal gland, and membranes that cover the surface of the brain 3D vector illustration

Mergers & acquisitions

Servier Adds to Childhood Brain Tumor Portfolio With $2.5B Day One Buy

Servier will pick up Ojemda, which received FDA approval in 2024 to treat pediatric glioma. The drug clocked sales of $155 million for Day One Biopharmaceuticals in 2025.

March 6, 2026

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1 min read

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Annalee Armstrong

FDA

FDA’s Prasad To Depart FDA Following Tumultuous Term as CBER Chief

Center for Biologics Evaluation and Research Director Vinay Prasad will exit the FDA for the second time after a controversial run that saw the oncologist butt heads with colleagues and ruffle feathers in biopharma after presiding over the rejection of several rare disease therapies.

March 6, 2026

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3 min read

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Heather McKenzie

Press Releases

argenx to Present New Data at 2026 AAN Annual Meeting that Continue to Transform Patient Outcomes in MG and CIDP and Build Upon Strength of Pipeline

March 6, 2026

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23 min read

Press Releases

Sciwind Biosciences Announces Ecnoglutide Injection Approved by China’s National Medical Products Administration (NMPA) for Chronic Weight Management