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1619 News Found

Alembic receives tentative U.S. FDA approval for Dabigatran Etexilate capsules
Drug Approval | November 23, 2021

Alembic receives tentative U.S. FDA approval for Dabigatran Etexilate capsules

Dabigatran Etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE)


Zydus Cadila submits NDA to Drug Controller General of India for Chronic Kidney Disease
Biotech | November 23, 2021

Zydus Cadila submits NDA to Drug Controller General of India for Chronic Kidney Disease

The NDA for Desidustat is based on positive data from the DREAM-ND and DREAM-D Phase 3 trials in patients with Chronic Kidney Disease (CKD) Not on Dialysis and Dialysis


European Commission approves Roche’s Gavreto
Drug Approval | November 22, 2021

European Commission approves Roche’s Gavreto

Gavreto is the first and only precision medicine approved in the EU for first-line treatment of people with RET fusion-positive advanced NSCLC


Merck showcases potential for several cancers, MS and lupus
News | November 22, 2021

Merck showcases potential for several cancers, MS and lupus

Five potential first-in-class assets aimed at delivering significant long-term growth. Over 14 clinical development programs underway across portfolio and 11 new studies to start in 2022 across early- and late-stage pipeline


Funding push to pharma R&D critical for unleashing next phase of growth
News | November 20, 2021

Funding push to pharma R&D critical for unleashing next phase of growth

The industry is at an inflection point and it awaits mega investments, the right government policies, and the creation of a strong ecosystem to propel innovation


U.S. FDA grants breakthrough designation to Datar’s blood test to detect breast cancer
Drug Approval | November 20, 2021

U.S. FDA grants breakthrough designation to Datar’s blood test to detect breast cancer

It is the first blood test able to detect early-stage Breast Cancer with high accuracy in women above the age of 40 years


Novo Nordisk to acquire Dicerna Pharmaceuticals for US $ 3.3 bn
Biotech | November 20, 2021

Novo Nordisk to acquire Dicerna Pharmaceuticals for US $ 3.3 bn

Dicerna develops RNAi-based therapies to selectively silence genes that cause or contribute to disease


Zydus Cadila receives U.S.FDA approval for leukaemia injection
Drug Approval | November 18, 2021

Zydus Cadila receives U.S.FDA approval for leukaemia injection

Nelarabine is in a class of medications called antimetabolites


Pfizer seeks EUA from U.S. FDA for Covid-19 drug
Biotech | November 17, 2021

Pfizer seeks EUA from U.S. FDA for Covid-19 drug

If approved or authorized, Paxlovid would be the first oral antiviral of its kind, to combat SARS-CoV-2


Biocon Biologics and Viatris announce US launch of Semglee
News | November 17, 2021

Biocon Biologics and Viatris announce US launch of Semglee

Branded and unbranded versions of the first-ever interchangeable biosimilar in the U.S. provide more affordable options for the millions of Americans living with diabetes