Drug Filing

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.

Ocugen signs agreement with Bharat Biotech to distribute Covid-19 vaccine in the US

Ocugen, a Pennsylvania-based pharmaceutical company, has signed an agreement with Bharat Biotech, an Indian pharma developer of COVAXIN, a Covid-19 vaccine, to distribute the vaccine in the US.

Bayer announces FDA accepts NDA and grants priority review for Finerenone for patients with CKD and T2D

Bayer announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) and granted Priority Review for finerenone, an investigational drug for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D).

GSK, MMV filing for Kozenis in paediatric populations with P. vivax malaria accepted by Australian TGA

GSK and Medicines for Malaria Venture (MMV) announced today that the Australian Therapeutic Goods Administration (TGA) accepted the submission of a Category 1 application to extend the indication of single-dose Kozenis (tafenoquine) to paediatric populations for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria.

CURE Pharmaceutical receives FDA approval for IND application for erectile dysfunction product CUREfilm Blue

CURE Pharmaceutical Holding, a technology focused, vertically integrated drug delivery and product development company in the pharmaceutical and health & wellness space, announced today that the U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) application for its product CUREfilm Blue, an oral soluble film of sildenafil citrate (the active ingredient present in Viagra®1) for the treatment of erectile dysfunction (ED).

FDA accepts Hepion’s IND application for CRV431 to treat Covid-19

The US Food and Drug Administration (FDA) has accepted Hepion Pharmaceuticals’ investigational new drug (IND) application for its CRV431, a novel cyclophilin inhibitor, to treat Covid-19.

FDA grants priority review to KEYTRUDA for treatment of esophageal and gastroesophageal junction cancer

Merck announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum and fluoropyrimidine based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus and gastroesophageal junction (GEJ).

Merck gets positive CHMP opinion for Keytruda as first-line treatment for dMMR colorectal cancer

Merck (known as MSD outside the US and Canada) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.

European CHMP adopts positive opinion for Dynavax’s HEPLISAV-B vaccine for Hepatitis B

Dynavax Technologies announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the company's Marketing Authorization Application, recommending the granting of marketing authorization for HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted] for the active immunization against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.