Tag: USFDA
SynaptixBio awarded second FDA Orphan Drug Designation to boost search for...
The leading biotech company is now aiming to develop treatment for second variant of TUBB4A leukodystrophy
Quality enhancement takes center stage at IPA’s 8th Advanced GMP Workshop
The Workshop took place virtually on 3-4 October 2023, with 20+ subject matter experts, industry leaders and global regulators from USFDA, MHRA, CDSCO
Lupin announces resolution of US FDA warning letter for its Goa...
This is after the satisfactory evaluation of the corrective actions taken by the company in response to the Warning Letter that was issued on November 6, 2017
Majority of pharma industry to grow at 7-9% in FY2024: ICRA
USFDA inspections have gained momentum in the recent past and regulatory risks remain a key monitorable
GSK launches Shingrix in India- A vaccine for the prevention of...
New data show Shingrix can provide at least 10 years of protection against shingles in adults aged 50 years and over
Concept Medical receives US-FDA’s IDE approval for its Magic Touch PTA
In BTK indication for its Sirolimus Coated Balloon Magic Touch PTA
Takeda’s dengue vaccine candidate granted priority review by US-FDA
TAK-003 is being evaluated for the prevention of dengue disease caused by any dengue virus serotype in individuals 4 years through 60 years of age
7th advanced GMP workshop by IPA to strengthen manufacturing practices &...
The workshops help improve the understanding on core issues such as quality management, global best practices, and new technologies in manufacturing
US FDA issues observations for Biocon Biologics sites
At the conclusion of these inspections, the agency has issued Form 483s with 11 observations each for the two sites in Bengaluru and 6 observations for the Malaysia site
USFDA approves expanded use of Bristol Myers immunotherapy for cancer
The approval marks the first-and-only immunotherapy-based treatment for use before surgery for non-small cell lung cancer