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The agency has concluded that an extra dose of the COVID-19 vaccines may be given to those individuals with severely weakened immune systems.

EMA Recommends Boosters of Pfizer and Moderna COVID-19 Vaccines for Some Individuals

The agency’s human medicines committee approved an additional site in West Point, Pa. in the United States for the manufacture of Janssen’s COVID-19 vaccine. 

EMA Approves Manufacturing Site for Janssen COVID-19 Vaccine 

EMA's CHMP is going to perform an accelerated assessment of data submitted by Moderna regarding the use of a booster dose of Spikevax. 

CHMP Performs Accelerated Assessment of Booster Dose of Spikevax

USP is publishing the analytics-focused chapter, which considers validation activities, in advance of the official publication.

USP Publishes General Chapter 1220 of Analytical Procedure Life Cycle

 Washington Editor, jillwechsler7@gmail.com.

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.

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