BioSpace News Archive

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Bladder cancer

Merck, Pfizer’s Drug Combo ‘Rewrites the Standard of Care’ in Bladder Cancer

A combination of Merck’s Keytruda and Pfizer’s Padcev could offer a chemotherapy-free treatment alternative for patients with muscle-invasive bladder cancer, even those eligible for cisplatin treatment.

March 2, 2026

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2 min read

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Tristan Manalac

Pictured: Front view of the CDC museum in Georgia

CDC

RFK Jr. Appoints 2 New Advisors to CDC Vaccine Panel Ahead of March Meeting

One of the two new members of the CDC’s Advisory Committee on Immunization Practices questioned the safety of COVID-19 vaccines before the Texas Senate in 2021.

March 2, 2026

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2 min read

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Tristan Manalac

IPO

Generate Arrives on Nasdaq Ready To Finally Show the World AI-Powered Medicines

Generate:Biomedicines has hit the public markets as the world begins to question the usefulness of AI technology. CEO Mike Nally says biology is the key to unlocking the technology’s full potential.

March 2, 2026

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3 min read

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Annalee Armstrong

Approvals

Ascendis Enters Achondroplasia Arena as FDA Approves First Weekly Drug

Yuviwel will compete with BioMarin’s Voxzogo. Meanwhile, BridgeBio is working to bring its own achondroplasia drug, the FGFR3 blocker infigratinib, to the market.

March 2, 2026

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2 min read

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Tristan Manalac

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Rare disease

Aardvark Tanks After Pausing Prader-Willi Study on ‘Surprise’ Safety Signals

Aardvark Therapeutics is down 54% since Friday after the biotech said it detected “reversible cardiac observations” in a healthy volunteer study of its drug to treat extreme hunger in patients with the rare genetic disease.

March 2, 2026

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2 min read

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Tristan Manalac

Medicine Pill Treatment Seamless Vector Flat Pattern

Manufacturing

Novo Commits $506M To Repurpose Irish Plant for Oral Wegovy Production

As Novo Nordisk continues to lose ground in the obesity market to rival Eli Lilly, the Danish company has started construction projects to establish the ex-Alkermes plant as a hub for supplying oral GLP-1 products to global markets.

March 2, 2026

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2 min read

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Nick Paul Taylor

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Layoffs

BioAtla Axes 70% of Staff, Explores Strategic Options

Less than a year after cutting roughly 30% of its employees, BioAtla is letting go of an even larger chunk of its workforce as it considers its future, which could include strategic partnerships and selling off assets.

March 2, 2026

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1 min read

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Angela Gabriel

A scientist with pill bottles in front of FDA headquarters

Regulatory

FDA Action Alert: BMS, GSK, Aldeyra and More

On the FDA’s docket this month are two decisions pushed back from 2025, including one for a rare form of obesity and another for dry eye disease.

March 2, 2026

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4 min read

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Tristan Manalac

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Rare disease

UniQure Eyes Phase 3 for Huntington’s Gene Therapy Despite Makary’s Apparent Criticism

Days after FDA Commissioner Marty Makary appeared to malign uniQure’s AMT-130 in an interview with CNBC, the agency confirmed to the biotech that a sham surgery–controlled study is needed before submitting the gene therapy for approval.

March 2, 2026

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3 min read

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Heather McKenzie

Press Releases

[Ad hoc announcement pursuant to Art. 53 LR] Roche’s fenebrutinib confirms its potential as first and only BTK inhibitor for relapsing and primary progressive MS in third positive Phase III study (FENhance 1)

March 2, 2026

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9 min read