FDA Drug Approvals Surging Despite Internal Changes
Despite initial concerns about a potential slowdown in FDA approvals under the new administration, the agency has been granting approvals at a near record-setting pace. In May, approvals dipped to 14 drugs after reaching 20 or more in previous months, but the total of 84 approvals so far in 2025 is second only to the record high set in 2024 for the same time period, according to Clarivate.
Among the approvals are 16 novel drugs covering a range of therapeutic areas such as oncology, rare diseases, and pain management. This surge in approvals comes amidst a major reorganization and workforce reduction effort within the FDA, which saw layoffs of 3,500 staff members earlier this year. Staffing disruptions have continued as new leaders are appointed and others choose to leave, with the recent announcement of the retirement of the acting head of CDER, Jacqueline Corrigan-Curay.
Gilead’s Breakthrough HIV Treatment
Gilead Sciences’ new formulation for its pre-exposure prophylaxis (PrEP) lenacapavir has garnered attention for its potential to revolutionize HIV prevention. The drug, marketed as Yeztugo, offers 100% protection against HIV and is administered only twice a year, setting it apart from existing PrEP regimens. However, concerns about patient access and global rollout remain, particularly in regions heavily impacted by HIV.
Daiichi Sankyo’s ADC Success
Daiichi Sankyo continues its success in the antibody-drug conjugate (ADC) space with approvals for its drug Enhertu and the AstraZeneca-partnered Datroway. The company aims to bring five ADCs to market for 30 different indications by 2030, with Datroway expected to surpass blockbuster levels in sales. The collaboration between Daiichi Sankyo and AstraZeneca highlights the potential for significant growth in the ADC market.
GSK’s Innovative Antibiotic
GSK’s recent approval of Blujepa, a first-in-class antibiotic for urinary tract infections, marks a significant milestone in antibiotic innovation. The drug’s unique mechanism of action and novel binding site set it apart from existing treatments, making it a promising addition to GSK’s portfolio. With a goal to launch five new products this year, GSK is positioning itself for growth in oncology and respiratory disease markets.
Overall, the FDA’s continued pace of approvals amidst internal changes and disruptions highlights the agency’s commitment to advancing innovative treatments and therapies for various diseases. As pharmaceutical companies push forward with groundbreaking drugs, the landscape of healthcare continues to evolve with new possibilities for patients worldwide.
