Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 6

Results For "regulatory-affairs"

64 News Found

USFDA issues final guidance on voluntary recalls
News | March 04, 2022

USFDA issues final guidance on voluntary recalls

The guidance also urges companies to act quickly to initiate a recall when public health is at risk and to do so prior to completing an investigation into the cause of the problem


USFDA grants Breakthrough Therapy Designation for Idiopathic Pulmonary Fibrosis therapy
Biotech | February 25, 2022

USFDA grants Breakthrough Therapy Designation for Idiopathic Pulmonary Fibrosis therapy

Boehringer Ingelheim plans to study this novel investigational therapy in patients with progressive fibrosing interstitial lung diseases


CDSCO recommends EUA for Corbevax in age group 12-18 years
News | February 15, 2022

CDSCO recommends EUA for Corbevax in age group 12-18 years

The recommendation has been sent to the DCGI for approval


Serum receives green light for Omicron variant vaccine
News | February 07, 2022

Serum receives green light for Omicron variant vaccine

Pfizer and Moderna are also working on vaccines that target the Omicron variant


Sauri Gudlavalleti is the new Chief Operating Officer of Sai Life Sciences
People | January 19, 2022

Sauri Gudlavalleti is the new Chief Operating Officer of Sai Life Sciences

He holds nine US patents and has published in multiple peer-reviewed journals and conferences


Olympus lays out its plans for growth in the medical business
Digitisation | December 08, 2021

Olympus lays out its plans for growth in the medical business

Investment in single-use endoscopes, digital solutions, and endoluminal therapies expected


Gan & Lee gets U.S. FDA clearance for novel glucagon-like peptide-1 analogue
Biotech | December 07, 2021

Gan & Lee gets U.S. FDA clearance for novel glucagon-like peptide-1 analogue

The investigational compound, GZR18, is a novel analogue of glucagon-like peptide-1 (GLP-1), an incretin hormone responsible for many glucoregulatory effects


Booster dose  for those above 40
News | December 03, 2021

Booster dose for those above 40

The recommendation was made by the Indian SARS-CoV-2 Genomics Sequencing Consortium (INSACOG), a network of national testing labs set up by the government to monitor genomic variations of Covid-19


Serum seeks DCGI approval for booster dose in India
News | December 02, 2021

Serum seeks DCGI approval for booster dose in India

The UK’s Medicine and Healthcare products Regulatory Agency has already approved the booster dose of AstraZenenca’s Covid-19 vaccine, which is administered in India


Pharma firms switch to advanced pharma manufacturing
Supply Chain | November 27, 2021

Pharma firms switch to advanced pharma manufacturing

Market demand for significant volumes and quality of biopharma products would drive continuous manufacturing technologies