The US FDA approved 1 NDAs and 2 BLA in October 2022, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 66 novel products in 2022
In October 2022, the major highlights drugs were Tecvayli’s approval for relapsed or refractory multiple myeloma, Furoscix for congestion in chronic heart…
The US FDA has approved 4 NDAs and 2 BLAs in 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 61 novel products in 2021
Additionally, last year in 2020, the US FDA…
In an interview with PharmaShots, Dr. Bassil I. Dahiyat, President and CEO of Xencor shared his views on the company's collaborations with BMS and its Xtend XmAb technology. He also shed light on the EUA of Sotrovimab for COVID-19.
Shots:
The FDA has granted EUA to Vir and GSK's sotrovimab, which was engineered with Xencor's XmAb…
In an interview with PharmaShots, Dave Marek. CEO of Myovant shares insights on the US FDA's approval of Myfembree (relugolix 40mg, estradiol 1mg, and norethindrone acetate 0.5mg) in Uterine Fibroids.
Shots:
The US FDA has approved Myovant & Pfizer's Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) as the first once-daily treatment for the…
In an interview with PharmaShots, Mike Crichton, Senior Vice President, Global Therapy Area Head, Specialty & Primary Care at GSK shares his views on the European Commission's approval of Benlysta (belimumab) in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis (LN).
Shots:
The European Commission approved the expanded use of GSK's…
In an interview with PharmaShots, Prof. Dr. Med. Steven Hildemann, Executive Vice President, Chief Medical Officer, Head of Global Medical Affairs, and Patient Safety of Ipsen share his views on the approval of the combination regimen for aRCC. He also shed light on the company's near-term goals in the coming years.
Shots:
The EC approval is based…
Shots:
In an interview with PharmaShots, Dr. Ahmet Sezer, Sanofi's Peter C. Adamson, and Regeneron's Israel Lowy shared their views on the US FDA's approval of Libtayo and the data supporting the approval.
Regeneron and Sanofi received the US FDA's approval for Libtayo for the 1L treatment of patients with advanced NSCLC whose tumors have high PD-L1 expression (tumor proportion score =50%), as…
The US FDA has approved 7 NDAs and 2 BLA in Dec 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 105 novel products so far in 2020, including 9 in Dec 2020.
Additionally, last year in 2019, 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 5 NDAs and 1 BLA in Nov 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 96 novel products so far in 2020, including 6 in Nov 2020.…

