The US FDA has approved 7 NDAs and 1 BLA in Feb 2021, 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 12 novel products in 2021.
Additionally, last year in 2020, the US…
The US FDA has approved 4 NDAs in Jan 2021, 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 4 novel products in 2021.
Additionally, last year in 2020, the US FDA has approved…
In a recent interview with PharmaShots, Ted Omachi, Global Development Leader for Xolair, and Senior Medical Director of Product Development for Immunology, Genentech shared his views on the approval of Xolair in the US.
Shots:
The approval is based on P-III POLYP 1 & 2 trials assessing Xolair vs PBO in 138 & 127 adult patients with…
The US FDA has approved 4 NDAs and 1 BLA in Oct 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 90 novel products so far in 2020, including 5 in Oct 2020.…
Pharma Middle East Virtual Congress (PPMC2020) layout many new ideas to resolve the most important problems related to the health and wellbeing of humanity. With all the scientific experts and professionals around the world focused on novel trends and advanced strategies emerging in the areas of pharma & chemistry, it provides unique learning and career-building…
The US FDA has accepted the sBLA for a new self-administration option for Xolair (omalizumab) across all approved US indications.
In an interview with PharmaShots, Ted Omachi the Global Development Leader for Xolair and Senior Medical Director of Product Development Immunology shares details and highlights of Xolair (omalizumab) PFS for self-administration.
Shots:
A decision on…
In the last 20 years the global Biopharma space has changed a lot with ups and downs of companies and their growth. This analysis has found the multiple acquisitions and mergers along with the launch of several blockbusters leading to jump in growth and revenue of numerous companies. Pfizer acquired Warner-Lambert in 2000 to gain…
