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8342 News Found

Pfizer granted USFDA Breakthrough Therapy Designation for RSV vaccine candidate
Drug Approval | March 24, 2022

Pfizer granted USFDA Breakthrough Therapy Designation for RSV vaccine candidate

The FDA decision is primarily informed by the positive results of a proof-of-concept, Phase 2a study evaluating the safety, immunogenicity, and efficacy of a single dose of 120µg RSVpreF in a human viral challenge model in healthy adults 18 to 50 years of age


Arum Therapeutics implements CDD Vault to streamline research data
Biotech | March 23, 2022

Arum Therapeutics implements CDD Vault to streamline research data

Arum's research focuses on the discovery of new chemical entities that will act as effective therapies for drug-resistant cancers


Lonza appoints Christian Seufert as President of CHI Division
People | March 23, 2022

Lonza appoints Christian Seufert as President of CHI Division

Christian brings a unique level of experience and expertise from a 20-year career at BASF across multiple territories and businesses


GMP certification for Exothera further extends its viral vector manufacturing capacity
Biotech | March 23, 2022

GMP certification for Exothera further extends its viral vector manufacturing capacity

The expansion makes Exothera one of the largest viral vector facilities in Europe


Merck’s Keytruda approved for fourth gynecologic cancer indication
Drug Approval | March 22, 2022

Merck’s Keytruda approved for fourth gynecologic cancer indication

The approval is based on new data from cohorts D and K of the KEYNOTE-158 trial


Indoco Remedies receives USFDA approval for Lacosamide tablets
Drug Approval | March 22, 2022

Indoco Remedies receives USFDA approval for Lacosamide tablets

According to IQVIA sales data for the period ending January 2022, Vimpat tablets market achieved annual sales of approx. US $ 1.7 billion


RNAGene and PharmAbcine to develop novel mRNA therapeutics
Biotech | March 21, 2022

RNAGene and PharmAbcine to develop novel mRNA therapeutics

mRNA-based therapies involve the administration of mRNA in patients so that patients' own cells can produce the encoded therapeutic antibody


Glenmark receives ANDA approval for Lacosamide tablets
Drug Approval | March 21, 2022

Glenmark receives ANDA approval for Lacosamide tablets

The company plans to launch the product immediately


USFDA approves Perrigo’s Nasonex
Drug Approval | March 21, 2022

USFDA approves Perrigo’s Nasonex

Nasonex is a registered trademark of Organon and is used by Perrigo and its affiliates under license


Zydus receives PAS approval for Mycophenolate Mofetil
Drug Approval | March 21, 2022

Zydus receives PAS approval for Mycophenolate Mofetil

The drug is indicated for use in combination with other drugs