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Daiichi Sankyo Submits Application for Additional Indication of Mirogabalin in Japan

New uses of Mirogabalin claimed by Daiichi...
May 17

Eyenovia Submits New Drug Application to FDA for Pharmacologic Mydriasis with MydCombi

The drug targets 80 Million Patient Encounters in the U.S. Annually...
Dec 31

Blueprint Medicines submits sNDA to USFDA for AYVAKIT for the treatment of advanced systemic mastocytosis

Blueprint Medicines requested priority review for this application, which, if granted, could result in a six-month review process...
Dec 18

Amgen Submits Sotorasib New Drug Application To U.S. FDA For Advanced Or Metastatic Non-Small Cell Lung Cancer With KRAS G12C Mutation

Amgen today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sotorasib, an investigational KRASG12C ...
Dec 17

FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine

Today, the U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (...
Dec 12

Meridian Bioscience submits application to FDA for Emergency Use Authorization for SARS-CoV-2 molecular assay

Meridian Bioscience, today announced that it has submitted its application for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for ...
Dec 09

Merck Submits Applications for Licensure of V114, the Company’s Investigational 15-valent Pneumococcal Conjugate Vaccine

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Nov 23

It’s all about keeping the patient connected to their doctor says, Dr. Monika Mehta, Co-founder, and CEO, Zealth-AI

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Nov 12

Bayer submits marketing authorization applications for finerenone in the U.S. and the EU

Finerenone for patients with chronic kidney disease and type 2 diabetes...
Nov 10

Janssen submits new drug application to U.S. FDA for treatment of schizophrenia in adults

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Nov 02

Janssen submits new drug application to U.S. FDA for treatment of schizophrenia in adults

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Nov 02

AbbVie submits regulatory applications to US FDA and EMA for RINVOQ (upadacitinib) in atopic dermatitis

These submissions are an important step forward in the commitment to providing an additional treatment option ...
Oct 20

Eton Pharmaceuticals submits new drug application to the FDA for Topiramate Oral Solution

Eton Pharma expects all three of the neurology product candidates to be approved and launched in 2021....
Oct 07

LuminUltra submits COVID-19 clinical diagnostic testing kit for regulatory authorization in U.S., Canada

End-to-end solution and components offer flexibility to testing facilities, meeting high-volume demand and significantly boosting global testing capacity ...
Sep 16

Siberia heatwave almost impossible without climate change

Experts have found that extreme heat events such as the Siberian hot spell would happen less than once every 80,000 years without human-induced ...
Jul 16

China publishes coronavirus genome data after Beijing outbreak

According to preliminary genomic and epidemiological study results, the virus is from Europe, but it is different from the virus currently spreading in Europe, an ...
Jun 19

AbbVie submits regulatory applications to FDA and EMA for RINVOQ

RINVOQ will be used for the treatment of adults with Active Psoriatic Arthritis...
Jun 08

Eisai Submits Marketing Authorization Application in Japan for Anticancer Agent Denileukin Diftitox (Genetic Recombinant)

For Cutaneous T-Cell Lymphoma and Peripheral T-Cell Lymphoma...
Mar 30

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