BioSpace News Archive

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FDA

FDA Drops Another Cache of Heavily Redacted Rejection Letters, Promises Future ‘Real-Time’ Access

Perhaps the most interesting of the pile of FDA rejection letters was for Lykos Therapeutics’ MDMA therapy. Letters sent to Stealth BioTherapeutics, Regeneron and more were also released as the agency also promised future CRLs “promptly after they are issued to sponsors.”

September 4, 2025

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4 min read

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Annalee Armstrong

2006 James Gathany Captured by James Gathany, Centers for Disease Control's biomedical photographer, this 2006 image depicted the exterior of the new "Tom Harkin Global Communications Center", otherwise known as Building 19, located on the organization's Roybal Campus in Atlanta, Georgia. The facility houses the CDC's Information Center/Library, auditoria and meeting halls, which are used to accommodate in-house staff meetings, and national/international conferences hosted by the CDC, and the National Center for Health Marketing's, Division of Creative Services, which includes a full service television broadcast facility. The exhibit area currently features the "Global Symphony", the first of several permanently installed exhibitions, and changing exhibitions that focus on a variety of public health topics. The exhibits in the Center are self-guided, and require no advance reservations. Additional curriculum-based exhibits and programming will be added in the future. Tom Harkin Global Communications Center Exhibit Area Centers for Disease Control and Prevention - 1600 Clifton Road, N.E., Atlanta, Georgia 30333 - Hours: Monday Friday, 9 am 5 pm, except for federal holidays Admission is free - Government-issue photo ID is required for entry. Please note that CDC is a working federal facility and as such does not provide public tours of its campus and laboratories. - For more information please call 404-639-0830.

CDC

ACIP Revamp Continues as Kennedy Eyes Seven New CDC Vaccine Advisors

The new additions would bring ACIP membership to 14 total. Several of the proposed members have taken part in anti-vaccine activity or made anti-vaccine statements.

September 4, 2025

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2 min read

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Dan Samorodnitsky

Press Releases

MRM Health Raises €55 Million Series B to Advance Best-in-Class Microbiome-Based Biotherapeutic Product Pipeline

September 4, 2025

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6 min read

Press Releases

Bruker Announces Pricing of Public Offering of $600 Million of 6.375% Mandatory Convertible Preferred Stock