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Sentynl Therapeutics receives USFDA acceptance and priority review of new drug application for CUTX-101 product candidate for treatment of Menkes disease
Drug Approval | January 07, 2025

Sentynl Therapeutics receives USFDA acceptance and priority review of new drug application for CUTX-101 product candidate for treatment of Menkes disease

Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A


Zydus inks agreement with CVS Caremark to add Zituvio, Zituvimet and Zituvimet XR to its template formulary
News | January 07, 2025

Zydus inks agreement with CVS Caremark to add Zituvio, Zituvimet and Zituvimet XR to its template formulary

These three NDAs of Sitagliptin (base) and combination franchise have been approved by the USFDA earlier through the 505(b)(2) route


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


Cenexi's Fontenay manufacturing facility receives 10 observations in ANSM inspection
Drug Approval | December 30, 2024

Cenexi's Fontenay manufacturing facility receives 10 observations in ANSM inspection

Cenexi is committed to working closely with the ANSM to address the observations


Sterling Biotech and Zydus Lifesciences agree to extend completion of business transfer
News | December 28, 2024

Sterling Biotech and Zydus Lifesciences agree to extend completion of business transfer

Zydus Lifesciences and SBL have mutually decided to extend the date of closing upto March 31, 2025


Kwality Pharmaceuticals receives approval for Tamoxifen 20mg Tablet in South Africa
News | December 26, 2024

Kwality Pharmaceuticals receives approval for Tamoxifen 20mg Tablet in South Africa

This approval is a significant achievement in expanding the availability of this critical therapeutic,


Alembic Pharmaceuticals receives USFDA final approval for Divalproex Sodium Delayed-Release Capsules
Drug Approval | December 22, 2024

Alembic Pharmaceuticals receives USFDA final approval for Divalproex Sodium Delayed-Release Capsules

Divalproex Sodium Delayed-Release Capsules USP, 125 mg have an estimated market size of US$ 61.1 million for twelve months ending September 2024 according to IQVIA


Lonza expands capsule manufacturing capacity in India and China
News | December 21, 2024

Lonza expands capsule manufacturing capacity in India and China

New capsule manufacturing lines added at Lonza Capsules & Health Ingredients (CHI) facilities in Rewari and Suzhou


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


Brenntag Specialties engages Esprit Care for its Southeast Asia nutraceutical market expansion
Supply Chain | December 12, 2024

Brenntag Specialties engages Esprit Care for its Southeast Asia nutraceutical market expansion

Brenntag Specialties Pharma marks a strategic milestone with its first collaboration with a contract manufacturer to enhance its nutraceutical value chain