2023 New Drug Approvals: Review of New FDA and EMA Marketing Authorisations
Tribeca Knowledge
NOVEMBER 28, 2023
T he drug-approval slump in major markets that clouded innovation prospects during 2022 seems to be over.
Tribeca Knowledge
NOVEMBER 28, 2023
T he drug-approval slump in major markets that clouded innovation prospects during 2022 seems to be over.
European Pharmaceutical Review
AUGUST 14, 2023
The US Food and Drug Administration (FDA) has approved Janssen’s Akeega (niraparib and abiraterone acetate), for the treatment of adult patients BRCA-positive metastatic castration-resistant prostate cancer (mCRPC). The FDA approval was based on positive results from the multi-centre Phase III MAGNITUDE study.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Pharma Leaders
MAY 18, 2023
The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy.
Pharmaceutical Technology
APRIL 19, 2023
While the Clarksville, US-based company completed a Phase Ia study in healthy participants to eventually develop the drug for Alzheimer’s disease, it is likely that the company will now focus on Parkinson’s disease in its Phase II study first, said Kelleher-Andersson. Similarly, research collaborations are also a consideration.
European Pharmaceutical Review
JUNE 27, 2023
difficile in December 2022, the microbiome therapies space in 2023 has continued to see revolutionary developments and continued research advancement. Notably, gut microbiome was found to linked to cancer CAR T therapy response, based data from the largest prospective study of its kind, published in Nature Medicine in March 2023.
Contrarian Sales Techniques
DECEMBER 14, 2022
The biotechnology and drug sectors performed well in the second half of 2022 after struggling in the first six months. Despite the uncertainty surrounding the global economy, the drug and biotechnology sectors have continued to perform well in the second half of 2022. This can lead to significant losses for large companies.
European Pharmaceutical Review
DECEMBER 28, 2023
Finally, Andreas looks at the prospects for antibodies that target the innate immune system in treating both haematological malignancies and solid tumours. We received encouraging feedback from the US Food and Drug Administration (FDA) on the trial design and potential for accelerated approval.
Let's personalize your content