Approvals

Johnson & Johnson’s Covid-19 vaccine receives interim order authorisation in Canada

Johnson & Johnson has secured authorisation for its Covid-19 vaccine under interim order (IO) from Health Canada for emergency use.

EMA validates Pfizer and OPKO’s somatrogon marketing application for review

The European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for Pfizer and OPKO’s somatrogon, for review.

ViiV Healthcare seeks USFDA approval to expand Cabenuva use for HIV-1 infected adults

Specialist HIV company ViiV Healthcare has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) to expand the use of Cabenuva.

USFDA accepts priority review for Pfizer’s TicoVac

Pharmaceutical company Pfizer has announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for priority review for TicoVac, a tick-borne encephalitis (TBE) vaccine.

AstraZeneca withdraws Imfinzi indication in US for bladder cancer

AstraZeneca has voluntarily withdrawn the Imfinzi (durvalumab) indication for adult patients who received treatment earlier in the US for locally advanced or metastatic bladder cancer.

USFDA grants FTD to efanesoctocog alfa for hemophilia A treatment

The U.S. Food and Drug Administration (FDA) has granted efanesoctocog alfa – earlier termed BIVV001 (rFVIIIFc-VWF-XTEN) – Fast Track Designation (FTD) for the treatment of patients suffering from hemophilia A.

USFDA approves EUA for bamlanivimab-etesevimab combo to treat Covid-19 patients

The U.S. Food and Drug Administration (FDA) has approved Emergency Use Authorization (EUA) for investigational bamlanivimab and etesevimab as a combination therapy for the treatment of mild to moderate Covid-19 patients.

USFDA approves Libtayo for skin cancer treatment

The US Food and Drug Administration (FDA) has approved Libtayo to be used for the treatment of patients having two of the most common skin cancers in the US.

USFDA awards Breakthrough Therapy designation to Novartis’ asciminib

Novartis has announced that the novel investigational treatment asciminib, specifically targeting the ABL myristoyl pocket (STAMP), has been awarded Breakthrough Therapy designation (BTD) by the US Food and Drug Administration (FDA).