Quality/GMPs

FDA’s emergency use authorization will double rapid at-home COVID-19 testing capacity.

The agency received a marketing authorization application a monoclonal antibody treatment for COVID-19 patients.

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

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.

FDA and EMA are looking to tap real-world data and real-world evidence more broadly to accelerate the research and market approval process.

Public health challenges have highlighted the need for agility in maintaining the quality of medicines.

Establishing bioassay studies for biosimilar development is important for supporting regulatory filings.

A new program will test the safety and suitability of new inactive ingredients to encourage the accelerated adoption of FDA-accepted excipients in drug development.

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

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about aseptic processing.

FDA granted orphan drug designation to Catalyst Biosciences’ MarzAA for the treatment of Factor VII Deficiency.

FDA approved AbbVie’s Qulipta (atogepant) as a preventative migraine treatment.

GeneTx Biotherapeutics and Ultragenyx Pharmaceutical announced that FDA has removed the clinical hold on GTX-102, an investigational treatment for Angelman syndrome.

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

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

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.

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

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

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.

Health Canada approved the new drug submission for Spikevax—more commonly known as the Moderna COVID-19 vaccine—for active immunization to prevent COVID-19 in individuals 12 years of age and older.

FDA revised the emergency use authorization for bamlanivimab and etesevimab (administered together) to include emergency use as post-exposure prophylaxis (prevention) for COVID-19.

Democrats failed to gain sufficient support to advance long-debated legislation to permit Medicare drug price negotiations.

Takeda’s Exkivity (mobocertinib) was approved by FDA for the treatment of patients with lung cancer.

FDA and EMA will provide scientific advice to applicants concerning complex generic and hybrid products.

HUTCHMED’s amdizalisib (HMPL-689) received breakthrough therapy designation for the treatment of a subtype of non-Hodgkin’s lymphoma.