Tags : the US FDA

Insights+

Insights+: The US FDA New Drug Approvals in July 2020

The US FDA has approved multiple NDAs and BLAs in July 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 59 novel products so far in 2020, including 8 in July 2020. Additionally, […]Read More

Insights+

Insights+: The US FDA New Drug Approvals in June 2020

 The US FDA has approved multiple NDAs and BLAs in Jun 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 51 novel products so far in 2020, including 8 in Jun 2020. Additionally, […]Read More

Regulatory

Otsuka Inqovi (decitabine and cedazuridine) Received the US FDA’s Approval

Shots: The approval was based on P-III trial from the ASCERTAIN study supporting P-I and P-II clinical studies which evaluated the safety and efficacy including decitabine exposure equivalence in oral Inqovi vs intravenous decitabine Otsuka a subsidiary of Astex Pharmaceuticals with its partner Taiho Pharmaceutical and North American reported the approval Inqovi is a novel […]Read More

Regulatory

Pfizer with its Partner BioNTech Receives the US FDA’s Fast

Shots: The designation is based on preliminary data from P-I/II study assessing BNT162b1 including animal immunogenicity studies results that were released on Jul 01, 2020. Additionally, the early results of German trial evaluating BNT162b1 are expected in Jul 2020 The companies BNT162 mRNA-based vaccine program involves the evaluation of 4 investigational candidates developed to target […]Read More

MedTech

Abbott’s Gallant ICD and CRT-D Devices Receives the US FDA’s

Shots: Abbott’s Gallant implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) are developed for heart rhythm disorders including patient-preferred design without compromising battery longevity and MRI compatibility also allows Bluetooth connectivity on the smartphones for improved remote monitoring, increased patient/physician engagement and streamlined communications The Gallant pairs with Abbott’s secure myMerlinPulse for streamline communication […]Read More