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Results For "U.S"

1563 News Found

CDSCO approves Wockhardt’s Mignaf for treatment of community acquired bacterial pneumonia
Drug Approval | January 05, 2025

CDSCO approves Wockhardt’s Mignaf for treatment of community acquired bacterial pneumonia

Wockhardt plans to launch Miqnaf in the Indian market in coming few months


FDA grants orphan drug designation to MicuRx's MRX-5 for non-tuberculous mycobacteria infections
Drug Approval | January 02, 2025

FDA grants orphan drug designation to MicuRx's MRX-5 for non-tuberculous mycobacteria infections

MRX-5 is a novel benzoxazole antibiotic developed for the treatment of mycobacteria infections, particularly infections caused by non-tuberculous Mycobacteria


Innovent inks agreement with Roche for Novel DLL3 ADC
News | January 02, 2025

Innovent inks agreement with Roche for Novel DLL3 ADC

Innovent has granted Roche exclusive global rights to develop, manufacture and commercialize IBI3009


Immedica to acquire biopharmaceutical company Marinus Pharmaceuticals
News | December 31, 2024

Immedica to acquire biopharmaceutical company Marinus Pharmaceuticals

Immedica to commence a cash tender offer to acquire all issued and outstanding shares of Marinus for an enterprise value of approximately US$ 151 million


Sumitomo Pharma America receives USFDA approval of vibegron for benign prostatic hyperplasia
Drug Approval | December 27, 2024

Sumitomo Pharma America receives USFDA approval of vibegron for benign prostatic hyperplasia

GEMTESA is the first and only beta-3 agonist approved for the treatment of men with OAB symptoms who are receiving pharmacological therapy for BPH


USFDA approves Encorafenib plus Cetuximab and Chemo in BRAF V600E-positive mCRC
Drug Approval | December 21, 2024

USFDA approves Encorafenib plus Cetuximab and Chemo in BRAF V600E-positive mCRC

Accelerated approval is based on 61% overall response rate compared to 40% in control arm in the


Glenmark USA launches Lacosamide Oral Solution, 10 mg/mL
News | December 17, 2024

Glenmark USA launches Lacosamide Oral Solution, 10 mg/mL

According to IQVIATM sales data for the 12-month period ending October 2024, the Vimpat Oral Solution, 10 mg/mL market achieved annual sales of approximately $57.0 million


Granules India FDA approval for ADHD treatment
Drug Approval | December 17, 2024

Granules India FDA approval for ADHD treatment


Merck announces FDA acceptance of biologics license application for Clesrovimab
Drug Approval | December 17, 2024

Merck announces FDA acceptance of biologics license application for Clesrovimab

An investigational long-acting monoclonal antibody designed to protect infants from RSV disease during their first RSV season


Acoramidis receives positive CHMP opinion for treatment of transthyretin amyloid cardiomyopathy
Drug Approval | December 14, 2024

Acoramidis receives positive CHMP opinion for treatment of transthyretin amyloid cardiomyopathy

Final decision from the European Commission is anticipated within the coming months