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Results For "FDA"

2194 News Found

Zydus Cadila receives final approval from USFDA for Droxidopa capsules
News | February 20, 2021

Zydus Cadila receives final approval from USFDA for Droxidopa capsules

It is used to treat low blood pressure that causes severe dizziness or a lightheaded feeling.


Bayer’s asundexian demonstrated 26% reduction in stroke after a non-cardioembolic ischemic stroke
Clinical Trials | February 07, 2026

Bayer’s asundexian demonstrated 26% reduction in stroke after a non-cardioembolic ischemic stroke

These results were consistent across all clinically relevant patient subgroups regardless of key patient characteristics like age or sex, the cause of stroke or the severity of the stroke


Novo Nordisk threatens legal action over Hims & Hers ‘knockoff’ semaglutide pill
News | February 07, 2026

Novo Nordisk threatens legal action over Hims & Hers ‘knockoff’ semaglutide pill

The pharmaceutical giant said it would pursue legal and regulatory action following Hims & Hers


AstraZeneca & Daiichi Sankyo gain priority review for Datroway in hard-to-treat breast cancer
News | February 05, 2026

AstraZeneca & Daiichi Sankyo gain priority review for Datroway in hard-to-treat breast cancer

The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)


Lupin launches Topiramate ER capsules in US
News | February 05, 2026

Lupin launches Topiramate ER capsules in US

Topiramate Extended-Release Capsules are bioequivalent to the reference listed drug (RLD), Trokendi XR Extended-Release Capsules of Supernus Pharmaceuticals


Novo Nordisk weathers pricing pressure, bets big on oral Wegovy
News | February 05, 2026

Novo Nordisk weathers pricing pressure, bets big on oral Wegovy

Operating profit fell 1% in Danish kroner to DKK 127.7 billion but rose 6% at constant exchange rates


SPARC announces receipt of priority review voucher associated with Sezaby approval
News | February 04, 2026

SPARC announces receipt of priority review voucher associated with Sezaby approval

A PRV is a tradable voucher granted by the FDA to encourage the development of new treatments for rare pediatric diseases


Lonza posts CHF 6.5 billion in 2025 sales, marks strong profit growth
News | January 30, 2026

Lonza posts CHF 6.5 billion in 2025 sales, marks strong profit growth

Excluding Vacaville-related business, organic CER sales growth reached the low-teens with improved CORE EBITDA margins, in line with Lonza’s CDMO Organic Growth Model