 Washington Editor, jillwechsler7@gmail.com.

Articles

FDA is expanding its Emerging Technology Program and providing more support for new drug applications that present advanced manufacturing technologies. 

FDA Highlights Value and Challenges of Advanced Drug Manufacturing

Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) is the first FDA approved interchangeable biosimilar for Humira.

FDA Approves Cyltezo as Interchangeable Biosimilar with Humira

ANGUS’ planned expansion will double its tromethamine buffer production capacity.

ANGUS to Expand U.S. Manufacturing Capacity for Tromethamine Buffers

The council voted 19-0 to recommend that FDA authorize booster doses of the J&J COVID-19 vaccine just one day after granting Moderna a similar recommendation.

FDA Advisory Council Unanimously Supports Johnson & Johnson COVID-19 Booster EUA

Evonik’s LIPEX Flow extruder is a new version of its high-pressure equipment for manufacturing liposomal drug products.

Evonik Launches Next-Generation Liposomal Drug Manufacturing Equipment 

The council voted 19–0 to recommend that FDA authorize booster doses of the Moderna COVID-19 vaccine for certain populations.

FDA Advisory Council Unanimously Supports Moderna COVID-19 Booster EUA

In this collaboration, Takeda will utilize Poseida's biodegradable DNA and RNA nanoparticle delivery technology and other proprietary genetic engineering platforms for the research and development of gene therapies.

Poseida Therapeutics and Takeda Partner to Develop Non-Viral In-Vivo Gene Therapy Programs

MilliporeSigma announced the opening of its second Carlsbad, California-based facility, which doubles production capacity to support commercial and industrial manufacturing of viral vectors. 

MilliporeSigma Completes $110-Million Contract Development Manufacturing Facility for Gene Therapy

After months of deliberation, Biden plans to appoint cardiologist Robert Califf as FDA commissioner.

Can Califf Bring Clarity and Enhanced Credibility to FDA?

Aceto will acquire A&C Bio Buffer, including the company’s custom buffer and chemical blend portfolio.

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