Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 146

Results For "FDA"

2194 News Found

OneSource unveils new brand identity at CPHI Milan
News | October 11, 2024

OneSource unveils new brand identity at CPHI Milan

Aims to achieve CDMO sales of US$ 400 million by 2028


Briefs: NATCO Pharma, Mylan Pharmaceuticals, Novo Nordisk and Alembic Pharmaceuticals
News | October 09, 2024

Briefs: NATCO Pharma, Mylan Pharmaceuticals, Novo Nordisk and Alembic Pharmaceuticals

Mylan and Novo Nordisk reach settlement of US patent litigation related to Ozempic


Briefs: Aurobindo Pharma and Lupin
News | October 06, 2024

Briefs: Aurobindo Pharma and Lupin

USFDA completes PAI of Lupin’s biotech facility in Pune


Calquence granted priority review in US for patients with untreated mantle cell lymphoma
Drug Approval | October 06, 2024

Calquence granted priority review in US for patients with untreated mantle cell lymphoma

Based on ECHO Phase III trial which demonstrated Calquence combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy


Clariant to launch eight new high-performing excipients at the CPHI Milan 2024
News | October 03, 2024

Clariant to launch eight new high-performing excipients at the CPHI Milan 2024

Clariant is launching high-performing pharmaceutical ingredients to support the evolution of safe and effective medicines


Zydus receives EIR for the transdermal manufacturing facility
Drug Approval | October 02, 2024

Zydus receives EIR for the transdermal manufacturing facility

This facility underwent an inspection from 15th to 19th July 2024 and has been classified as Voluntary Action Indicated


Dr. Reddy’s signs licensing agreement with Gilead Sciences to manufacture and commercialise Lenacapavir
News | October 02, 2024

Dr. Reddy’s signs licensing agreement with Gilead Sciences to manufacture and commercialise Lenacapavir

Gilead Sciences first launched Lenacapavir under the brand name Sunlenca in the United States and Europe markets in the year 2022


Briefs: Lupin, Alembic Pharmaceuticals and Piramal Pharma
Drug Approval | September 29, 2024

Briefs: Lupin, Alembic Pharmaceuticals and Piramal Pharma

Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations


Sanofi’s dupixent approved in the US as the first-ever biologic medicine for patients with COPD
Drug Approval | September 27, 2024

Sanofi’s dupixent approved in the US as the first-ever biologic medicine for patients with COPD

Dupixent is indicated for the approximately 300,000 adults in the US with inadequately controlled COPD and an eosinophilic phenotype


Biocon Biologics announces new dermatology data to be presented at EADV Congress 2024
Biotech | September 25, 2024

Biocon Biologics announces new dermatology data to be presented at EADV Congress 2024

These clinical studies support the interchangeability of adalimumab-fkjp at low-concentration with high-concentration adalimumab and ustekinumab biosimilarity