All articles tagged with #drug approvals
The FDA is experiencing significant turmoil with high-profile staff departures, leadership resignations, and internal mistrust, raising concerns about its reliability and impact on drug approvals and public health, amid broader government downsizing and political pressures.
GoodRx Health has compiled a list of the most notable drug and vaccine approvals of 2023, selected by pharmacists. The list includes Paxlovid for COVID-19, Arexvy, Abrysvo, and Beyfortus for RSV, Opill for contraception, Zurzuvae for postpartum depression, Leqembi for Alzheimer's disease, OTC naloxone for opioid overdoses, Zepbound for chronic weight management, Roctavian for hemophilia A, and Casgevy and Lyfgenia for sickle cell disease. These approvals are seen as meaningful steps forward in improving human health and accessibility to treatments.
Pfizer's financial position is expected to benefit from recent events, including multiple drug and vaccine approvals, which will help offset potential revenue losses from exclusivity and reduced demand for the COVID-19 vaccine. The company's experimental drug, danuglipron, is poised to compete with leaders in the diabetes treatment market. Additionally, the FDA approval of Abrysvo for respiratory syncytial virus in older people opens up significant commercial opportunities. The recent FDA approvals of Litfulo and Ngenla further strengthen Pfizer's position in the pharmaceutical industry. Ngenla's entry into the US market is expected to drive strong sales growth and profit generation. With extensive long-term data and market recognition, Pfizer aims to regain its share of the global human growth hormone market. Despite a recent decrease in share price, technical analysis suggests a potential reversal upwards. The article concludes with an "outperform" rating for Pfizer.
Pfizer CEO Albert Bourla signed a letter along with over 200 pharmaceutical company executives in support of the FDA's authority to regulate drugs after a federal judge in Texas suspended the agency's approval of the abortion pill mifepristone. The executives raised concerns that the ruling will set a precedent for diminishing the FDA's authority over drug approvals, which would create uncertainty for the entire industry. The dueling orders by two federal judges create a complicated legal standoff that could potentially escalate to the Supreme Court.