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Results For "regulatory"

1134 News Found

Grace expands CDMO capacity by 25% of South Haven facility in Michigan
News | March 19, 2024

Grace expands CDMO capacity by 25% of South Haven facility in Michigan

Additional capacity broadens Grace’s fine chemical capabilities for API production


Sun Pharmaceuticals receives approval for Winlevi in Australia
Drug Approval | March 19, 2024

Sun Pharmaceuticals receives approval for Winlevi in Australia

Winlevi is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older


AstraZeneca to acquire Amolyt Pharma
News | March 18, 2024

AstraZeneca to acquire Amolyt Pharma

Acquisition to further expand the Alexion, AstraZeneca Rare Disease pipeline beyond complement inhibition


European Commission approves Pfizer’s Prevenar 20 to help protect infants and children against pneumococcal disease
Drug Approval | March 13, 2024

European Commission approves Pfizer’s Prevenar 20 to help protect infants and children against pneumococcal disease

PREVENAR offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine to help protect infants and children from the 20 serotypes responsible for the majority of currently circulating pneumococcal disease in the EU and globally


Pfizer announces positive Phase 3 trial of ADCETRIS regimen in patients with DLBCL
Diagnostic Center | March 12, 2024

Pfizer announces positive Phase 3 trial of ADCETRIS regimen in patients with DLBCL

Pfizer to discuss regulatory submission with FDA, potentially leading to eighth indication for ADCETRIS


Venus Remedies gets huge global acclaim with UNICEF GMP approval
News | March 12, 2024

Venus Remedies gets huge global acclaim with UNICEF GMP approval

Venus Remedies' manufacturing unit, located in Baddi, Himachal Pradesh, has been recommended for supplying cephalosporin dry powder to UNICEF


AbCellera and Biogen collaborate on neurological antibody therapy
News | March 12, 2024

AbCellera and Biogen collaborate on neurological antibody therapy

AbCellera will receive an upfront payment and is eligible to receive additional milestone payments


EMA validates MAAs for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan in two types of cancer
Drug Approval | March 07, 2024

EMA validates MAAs for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan in two types of cancer

The validations confirm the completion of the applications and commence the scientific review process


Briefs: Zydus, Advanced Enzyme Technologies, Link Pharma Chem and ANVISA
News | March 07, 2024

Briefs: Zydus, Advanced Enzyme Technologies, Link Pharma Chem and ANVISA

ANVISA issues CGMP to Concord Biotech’s Unit I


Nectar Lifesciences’ suo moto clarification on a news item
News | March 07, 2024

Nectar Lifesciences’ suo moto clarification on a news item

Nectar Lifesciences has clarified that the company has no relation/connection/ association or link of any nature with the Nectar Herbs and Drugs