Regeneron’s Pasatru Wins FDA Approval for FOP
The FDA approved Regeneron’s Pasatru for FOP, an ultra-rare bone disorder, after Phase 3 trials showed strong drops in new bone growth. FOP causes muscle,...
Tag : FDA
Aurobindo Pharma Gains 2% After US Plant Clears FDA Review
Aurobindo Pharma shares gained 2% on Monday morning after a US-based unit, Aurolife Pharma, cleared an FDA plant inspection with VAI status. The gain follows...
US Advisers Endorse Single-Shot Covid-19 Vaccine from J&J
US health advisers endorsed a one-dose COVID-19 vaccine from Johnson & Johnson on Friday, putting the nation on the cusp of adding an easier-to-use option to fight the pandemic....
US Approves First COVID-19 Self-Testing Kit to Test at Home
The United States Food and Drug Administration on Tuesday said that it has approved the first COVID-19 self-testing kit for individuals to test at home. The self-testing...
Cipla Zooms 14% on USFDA Nod for Generic Proventil
Cipla Ltd shares have gained as much as 16 per cent after the company received approval from the US Food and Drug Administration (USFDA) for...
Dr Reddy Shares Dipped Almost 7% Post Q4 Results
Dr Reddy Laboratories dipped around 7 per cent during an early morning trade through an equity benchmark indices saw a sharp upsurge. On Friday, the...
Aurobindo Pharma Receives 11 Observations From US FDA
The U.S. Food and Drug Administration has issued a form 483 with 11 observations to Aurobindo Pharma Ltd.’s Unit 16 in Telangana, which makes sterile...