Regulatory

Q3 Interim report November-January 2020/2021

FDA resumes review of DiviTum®TKa submission

March 18, 2021

Biovica’s DiviTumTKa prognostic for long-term outcome

Biovica, active in cancer diagnostics, today announced that the results from the breast cancer study PROMIX at Karolinska University Hospital is published in the scientific journal ESMO Open. The study showed that testing for TKa levels during early treatment is prognostic for the long-term outcome of preoperative chemotherapy.

March 11, 2021

Nomination Committee for Biovica for the 2021 Annual General Meeting

The Nomination Committee prior to the 2021 Annual General Meeting will consist of three members, who shall represent the two shareholders with the most number of shares who accept the assignment to be part of the Nomination Committee as of December 31, 2020, and the Chairman of the Board. The Nomination Committee then appoints a chairman among its members.

February 26, 2021

FDA resumes review of DiviTum®TKa submission

Biovica, active in cancer diagnostics, today announced that the US Food and Drug Administration (FDA) has resumed its review of Biovica’s 510(k)-submission for DiviTum®TKa.

January 29, 2021

FDA resource reallocation continues to impact DiviTum®TKa timeline

Biovica, active in cancer diagnostics, today announced that the US Food and Drug Administration (FDA) has indicated that its previously communicated reallocation of resources to address COVID-19 continues to impact the timeline for completion of the review of Biovica’s 510(k)-submission for DiviTum®TKa. The FDA currently estimates that the reallocation will last another 90 days, approximately, during which time the FDA will not be able to continue reviewing Biovica’s submission.

January 16, 2021

Biovica Q2 Interim Report August-October 2020/2021

Convincing study results and application submitted to the FDA – commercialization just around the corner

December 3, 2020

Biovica’s FDA submission will proceed to substantive review

Biovica, active in blood-based cancer diagnostics, today announced that the company’s 510(k) submission to the US Food and Drug Administration (FDA) for the blood test DiviTum®TKa will proceed to substantive review when the COVID-19 related pause ends.

November 13, 2020

FDA resource reallocation impacts DiviTum®TKa timeline

Biovica, active in cancer diagnostics, today announced that the US Food and Drug Administration (FDA) has indicated that it is reallocating resources to COVID-19 impacting the timeline for completion of the review of Biovica’s 510(k)-submission for DiviTum®TKa. The FDA currently estimates that the reallocation will last approximately 90 days during which time the FDA will not be able to continue reviewing Biovica’s submission.

October 30, 2020

Biovica completes 510(k) submission for DiviTum®TKa to the FDA

Biovica, active in blood-based cancer diagnostics, today announced that the company has filed a 510(k) submission with the U.S. Food and Drug Administration (FDA).

September 25, 2020

Bulletin from the annual general meeting in Biovica

The following resolutions were passed at the annual general meeting of Biovica AB (publ) on 27 August 2020 in Uppsala.

August 27, 2020