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The FDA approved 50 new drugs in 2023, including contributions from South Korea's Hugel and Yuhan Corporation. Notable approvals include treatments for NASH and schizophrenia. Cancer drugs led with 15 approvals. South Korea's FDA-approved drugs highlight its growing role in global pharmaceutical innovation.

December 2024 saw significant psychiatry developments: brilaroxazine's efficacy for schizophrenia, brexpiprazole with sertraline's rapid PTSD relief, and navacaprant's MDD trial failure. Lumateperone advanced as an MDD adjunctive therapy. Despite FDA's CRL for MDMA-assisted therapy, innovative treatments and ongoing research signal hope for 2025, addressing mental health crises and improving patient outcomes.

In 2024, the FDA approved 50 new drugs, focusing on cancer, with 15 approvals. Small molecules led with 32 approvals, followed by proteins and oligonucleotides. Notable approvals included a schizophrenia treatment and a NASH drug, marking significant advancements in therapeutic areas.

The schizophrenia market is forecasted to grow to $17 billion by 2031, driven by new adjunctive therapies. The report covers 7MM, offering insights into market trends, pipeline analysis, and strategic opportunities for stakeholders.

2024 saw significant medical breakthroughs, including gene therapy restoring hearing in children, the first genetically-edited pig kidney transplant into a human, discovery of a lupus cause, FDA approval of the first new schizophrenia drug class in over 30 years, and the first over-the-counter COVID-19 and flu test outside of emergency use.

2024 saw major medical breakthroughs: gene therapy restored hearing in children with hereditary deafness, the first genetically-edited pig kidney transplant was performed, a cause of lupus was discovered, the FDA approved a new schizophrenia drug, and the first over-the-counter combo flu and COVID test was authorized.

The schizophrenia market in 7MM is expected to grow at a CAGR of 7.4% from $8.4bn in 2021 to $17bn in 2031, driven by 11 late-stage pipeline products. These new products, with higher annual cost of therapy, will capture 33.4% of global sales in 2031. Cobenfy, approved in 2024, could become the top-selling drug with $2.2 billion sales in 2031. The US dominates the market due to a large patient population and high drug costs. Challenges include generic erosion of antipsychotic LAIs, but pipeline therapies will fuel market growth.

Adams Clinical, a Neuroscience-focused clinical trial site network, has agreed to partner with InSite Clinical Research, expanding its inpatient capabilities in Watertown, MA, and Bronx, NY, and entering Texas. The partnership enhances Adams’ expertise in psychiatric and neurologic illnesses, including Schizophrenia, and aligns with industry needs for high-quality inpatient and outpatient Psychiatry trials.

Dr. Horan, Dr. Sauder, Dr. Ramsay, and Dr. Yohn are Bristol Myers Squibb employees. Dr. Harvey has affiliations with multiple companies, including Bristol Myers Squibb. Dr. Ramsay holds Bristol Myers Squibb stock. Dr. Keefe consults for various companies and has received royalties. Dr. Davis consults for several companies. Dr. Paul has roles at Karuna Therapeutics, Sage Therapeutics, and Voyager Therapeutics. Dr. Brannan was with Karuna Therapeutics and now consults for Bristol Myers Squibb.