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 Washington Editor, jillwechsler7@gmail.com.

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The lack of a new permanent commissioner has hampered FDA in articulating future priorities and pushing back against miscommunications and outside complaints.

FDA Caught in the Political Crossfire

Biosimilar approvals and the advance of biosimilar testing and production may lead to greater access to alternative therapies.

Biosimilars Gain Traction with Regulators and Manufacturers

Researchers in China report test results for a microneedle patch for COVID-19 vaccine delivery.

Researchers Cite Positive Results in COVID-19 Microneedle Patch Trial

Biden outlines a plan to end the pandemic in a virtual global conference.

Biden Hosts Global COVID-19 Summit

The first and only approved antibody-drug conjugate for the treatment of recurrent or metastatic cervical cancer with disease progression on or after chemotherapy receives accelerated approval by FDA. 

FDA Grants Accelerated Approval for Recurrent or Metastatic Cervical Cancer Treatment to Tivdak

Boehringer Ingelheim to develop novel cancer therapies by leveraging Abexxa’s breakthrough antibody-based drugs.

Boehringer Ingelheim Acquires Abexxa Biologics, Expanding Cancer Treatment Potential

The FDA has amended the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to allow a single booster dose to several high-risk populations.

FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations

The agency approved Byooviz (ranibizumab-nuna), a biosimilar to Lucentis (ranibizumab injection), for the treatment of several eye diseases.

FDA Approves Biosimilar for Treatment of Eye Disease

Pfizer-BioNTech announced plans to seek FDA approval this month of a smaller dose of its Comirnaty vaccine for children ages 5–11.

Next Big COVID Challenge: Vaccines for Little Kids

FDA advisors agreed unanimously on a more limited booster plan after rejecting Pfizer’s original request to authorize its third shot for everyone over age 16.

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