- By: Bioxentys
- Author: Majo Villarraza
- CEO of Bioxentys & Pharma 4.0
The month of May 2024 has been particularly active for the pharmaceutical industry. Here’s a quick summary of the most important events aimed at industry professionals.
New Drug Approvals
In May 2024, the FDA granted accelerated approvals to several innovative drugs, including:
- Selpercatinib for metastatic thyroid cancer in pediatric patients (May 29).
- Tarlatamab-dlle for extensive-stage small cell lung cancer (May 16).
- Lisocabtagene maraleucel for follicular lymphoma (May 15).
These approvals highlight the FDA’s commitment to innovation and rapid access to essential treatments.
Safety Alerts and Drug Shortages
Drug shortages remain a challenge. In May, the FDA updated its list of drugs in shortage, including:
- Amoxicillin powder for suspension
- Atropine sulfate
- Azacitidine
- Cisplatin
- Fentanyl
These updates underscore the importance of efficient supply chain management and collaboration between manufacturers and distributors.
Developments in Generic and Biosimilar Therapies
In May, the first interchangeable biosimilar for Eylea to treat macular degeneration was approved (May 20). This advancement not only offers more affordable alternatives but also promotes competition in the biological drug market.
Key Reports and Resources
The FY 2023 report from the Generic Drug User Fee Amendments (GDUFA) Program, published on May 23, provides a detailed overview of the FDA’s efforts to ensure the quality and safety of generic drugs.
Grants and Research Funding
The FDA has announced several grants to support research and development in critical health areas. These funding opportunities can drive strategic projects and collaborations leading to new discoveries.
Clinical Trial Snapshots
The FDA’s Drug Trials Snapshots highlight clinical trial results for new drugs. In May, several drugs were presented, including:
- Zelsuvmi
- Tevimbra
- Frucazaqla
- Rystiggo
- Joenja
- Zurzuvae
To conclude,
May 2024 has been a month filled with significant advancements and ongoing challenges in the pharmaceutical industry. Staying informed about these developments is crucial for B2B professionals seeking to leverage opportunities and address market challenges.
For more details, visit the FDA’s official page dedicated to drug-related updates.
- Located in Palm Beach, Florida, USA, assists companies in entering the U.S. market for pharmaceuticals, cosmetics, dietary supplements, medical devices, and orphan drugs. Our regulatory experts offer services such as FDA registration, label review, and compliance workshops. With numerous success stories, we provide cost-efficient, tailored solutions to ensure market integration and growth.
- www.bioxentys.com
