Regulatory Authority Actions

Bylvay has minimal systemic exposure and acts locally in the small intestine as a potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi).

The MAA is supported by data from the pivotal Phase III GEMSTONE-302 trial that evaluated treatment with sugemalimab in combination with chemotherapy in patients with metastatic NSCLC.

FDA has announced that bebtelovimab is not currently authorized for emergency use in any region of the US.

The objectives of the new opportunity are to improve the quality and/or use of RWD, promote better understanding of RWE study designs, and develop specific tools to evaluate aspects of RWE generation.

FDA struggles to track shortages caused by a rise in demand.

Ferring Pharmaceuticals’ Rebyota was approved for the prevention of recurrence of Clostridioides difficile infection.

QMM is an evolutionary advancement in FDA’s quality management maturity initiative that provides industry with a viable methodology to assess and improve manufacturing quality and supply chain reliability.

The European Human Medicines Directive and Regulation is due to be updated by the end of 2022, but what changes are on the cards?

Health crises, political tension, and budget concerns were major challenges.

CSL’s Hemgenix (etranacogene dezaparvovec) will cost approximately $3.5 million, making it the most expensive single-use medicine in the United States.

NMPA has approved Ferinject in China for the treatment of iron deficiency or iron deficiency anemia.

Tzield (teplizumab-mzwv) injection is the first FDA-approved therapy designed to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older.

Initially rejected in July 2021, XPHOZAH (tenapanor) won recommendations as both a monotherapy and combination treatment from FDA’s CRDAC meeting.

The new facility will allow ReiThera to consolidate its competitive position as a leading CDMO specialized in viral vector production.

The results of the mid-term election may reduce Congress’ ability to pass FDA-related legislation during its lame duck session.

The UK MHRA has expanded the use of Cosentyx for use in pediatric arthritic conditions.

The latest guidance from FDA discusses recommendations on demonstrating sameness between the active ingredient in a proposed generic drug product and its reference listed drug.

FDA keeps its user fees but fails to gain important reforms.

Updates to general chapters on compounding, <795> Nonsterile Preparations and <797> Sterile Preparation, include requirements for equipment, cleaning, personnel garb, labeling, and surface contamination testing.

FDA has accepted Ashland’s Viatel bioresorbable mPEG-PDLLA pharmaceutical excipient into the FDA Novel Excipient Review Pilot Program.

A possible change in leadership on Capitol Hill has aggravated fears of political push-back on FDA regulation and approval of contraceptives and other medications.

AstraZeneca’s Imjudo (tremelimumab) was approved by FDA in combination with Imfinzi (durvalumab) for treating unresectable liver cancer.

An advisory committee’s vote to remove Makena from the market illustrates how difficult it is for regulators to ensure that such drugs document safety and effectiveness in a timely manner.

South Africa’s vaccine regulator has reached new WHO level to ensure safety, quality, and effectiveness.

The agency has recommended approval of Comirnaty and Spikevax for children from six months of age.

The agency has recommended authorization of the Spikevax COVID-19 vaccine that targets the Omicron variants BA.4 and BA.5.

Ebvallo (tabelecleucel) would be the first EMA-approved therapy for patients with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease.

Takeda’s dengue vaccine is designed to prevent disease caused by virus serotypes 1, 2, 3, and 4 in individuals four and older.

FDA amended its authorization for the Moderna and Pfizer-BioNTech bivalent booster vaccines to permit their use in children as young as five years old.

The UK’s MHRA has approved Colonis’ melatonin oral solution for sleep onset insomnia in children and adolescents with ADHD.