BioSpace News Archive

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Approvals

Boehringer Wins Speedy Lung Cancer Approval Under Commissioner’s Priority Program

Hernexeos is the second drug to secure an FDA approval under the agency’s priority voucher scheme, following in the footsteps of USAntibiotics’ Augmentin XR, which was granted the ticket in December 2025.

February 27, 2026

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2 min read

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Tristan Manalac

The Westin St. Francis in San Francisco, home of the J.P. Morgan Healthcare Conference.

Special edition

Deep Dive: BioSpace Takes On JPM26 in San Francisco

The BioSpace team hit the ground running at the J.P. Morgan Healthcare Conference earlier this month to bring you the news from the streets of San Francisco.

February 27, 2026

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2 min read

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Annalee Armstrong

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Vaccines

Uncertainty Looms Over Pharma’s Legal Strategy as States Challenge New Vaccine Schedule

The CDC’s changes threaten to cut vaccine sales for makers including Pfizer, Moderna, Merck and more, but a legal expert suspects affected manufacturers will stay on the sidelines rather than back a push to declare the revised schedule unlawful.

February 27, 2026

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2 min read

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Nick Paul Taylor

FDA commissioner Marty Makary speaking on a Youtube video, wearing a dark suit and a blue tie

Regulatory

Makary Defends FDA’s Decision-Making Amid Contentious Rare Disease Rejections

Without naming a specific product, Commissioner Marty Makary referred to an investigational therapy, delivered surgically into the brain, that the FDA was “pressured” to approve even after finding no clinical benefit to patients.

February 27, 2026

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2 min read

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Tristan Manalac

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Rare diseases

Rare Disease Groups Lobby for Regulatory Expediency as Makary Defends ‘Rigorous’ Approach

This week’s Capitol Hill meetings come on the heels of rejections of ultra-rare disease drugs developed by Biohaven and Saol Therapeutics. Physicians and patient groups implored the FDA to expedite these treatments.

February 27, 2026

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6 min read

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Heather McKenzie

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FDA

FDA To Offer Bonus Payments for Speedy Drug Reviewers

FDA Commissioner Marty Makary presented a new idea to staff this week: bonus payments for employees that complete regulatory review processes faster than expected.

February 27, 2026

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1 min read

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Annalee Armstrong

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FDA

Prasad Under Probe for Promoting Workplace Toxicity, Staffers Say

Aside from creating a toxic work environment, CBER Director Vinay Prasad has also been accused of berating his staff and retaliating against reviewers who questioned his decisions.

February 27, 2026

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2 min read

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Tristan Manalac

Press Releases

Press Release: Acoziborole Winthrop, developed by DNDi and Sanofi, receives CHMP positive opinion as three-tablet, single-dose treatment for most common form of sleeping sickness

February 27, 2026

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12 min read

Press Releases

Press Release: Sanofi and Regeneron’s Dupixent recommended for EU approval to treat chronic spontaneous urticaria in young children with ongoing symptoms despite treatment