Regulation

FDA approves Zealand Pharma’s Zegalogue for hypoglycemia treatment

Zealand Pharma has announced the US Food and Drug Administration (FDA) approval of its Zegalogue (dasiglucagon) injection for the treatment of patients aged six and above with severe hypoglycemia.

USFDA approves Janssen’s PONVORY for treatment of multiple sclerosis

Johnson & Johnson’s Janssen Pharmaceutical Companies have announced the US Food and Drug Administration (FDA) approval of PONVORY for the treatment of relapsing forms of multiple sclerosis (MS) in adults.

USFDA extends review period for AbbVie’s sNDA of upadacitinib

The US Food and Drug Administration (FDA) has extended the review period for AbbVie’s supplemental New Drug Application (sNDA) for upadacitinib.

Takeda submits New Drug Application for lanadelumab in Japan

Japan-based, R&D-driven Takeda Pharmaceutical Company Limited has submitted a New Drug Application (NDA) for lanadelumab to the Ministry of Health, Labour and Welfare (MHLW) in Japan.

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AstraZeneca has voluntarily withdrawn the Imfinzi (durvalumab) indication for adult patients who received treatment earlier in the US for locally advanced or metastatic bladder cancer.