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FDA casts doubt on clinical meaningfulness of Merck’s Keytruda trial data pharmaceutical-technology
February 09, 2021
The US Food and Drug Administration (FDA) has cast doubt on the results from Merck’s KEYNOTE-522 trial of Keytruda (pembrolizumab) submitted to support its expanded label in treating triple-negative breast cancer (TNBC).
FDA Announces Alert of Potential Risks Associated with Compounding of Remdesivir americanpharmaceuticalreview
February 08, 2021
The U.S. Food and Drug Administration (FDA) approved a new drug application (NDA) for Veklury (remdesivir), a drug indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 ...
Janssen seeks EUA for Covid-19 vaccine candidate from US FDA pharmaceutical-technology
February 07, 2021
Johnson & Johnson (J&J) unit Janssen Biotech has submitted an application seeking emergency use authorisation (EUA) for its investigational single-dose Covid-19 vaccine candidate to the US Food and Drug Administration (FDA).
Element Materials Technology Acquires Avomeen contractpharma
February 04, 2021
Element Materials Technology has acquired Avomeen, a pharmaceutical analytical testing company, significantly expanding the Group’s Life Sciences business unit in North America.
Glenmark Pharma receives US FDA nod for seizure treatment drug expresspharma
February 04, 2021
Glenmark Pharmaceuticals said Qudexy extended-release capsules market achieved annual sales of approximately US $120 mn.
Q BioMed's Uttroside-B Receives Orphan Drug Designation for Liver Cancer americanpharmaceuticalreview
February 03, 2021
Q BioMed announced the U.S. Food and Drug Administration's (FDA) Office of Orphan Products Development has granted Orphan Drug Designation to Uttroside-B, a small molecule chemotherapeutic for the treatment of hepatocellular carcinoma (HCC), the most ...
Granules India gets US FDA nod for Potassium Chloride Oral Solution expresspharma
February 02, 2021
Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis.
AstraZeneca’s Covid-19 vaccine gets EUA in Philippines pharmaceutical-technology
February 01, 2021
AstraZeneca has obtained emergency use authorisation (EUA) from the Philippines Food and Drug Administration (FDA) for its Covid-19 vaccine, granted following a detailed review by medical and regulatory experts in the country.
Immunoforge's 'PF1801' Is Designated as Orphan Drug by FDA prnasia
January 29, 2021
Immunoforge announced that their new drug candidate PF1801 has been designated as the FDA orphan drug for treatment of the Duchenne muscular dystrophy on January 25.
US FDA grants Orphan Drug Designation to Zydus’ Saroglitazar for primary biliary cholangitis treatment expresspharma
January 29, 2021
This follows the grant of ‘Fast Track Designation’ by the USFDA to Saroglitazar Mg for PBC in December 2020.

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