The U.S. FDA is not the only regulatory agency attempting to deal with impending and existing device and drug shortages, although some of the drivers of these shortages are not within these agencies’ purview.
In April, the U.S. FDA approved 26 new drugs, the sixth-highest monthly total going back to 2016. This is slightly lower than March’s record-setting 30 approvals, the highest count in BioWorld’s records. By comparison, the FDA approved an average of about 16 drugs per month in 2023, 12.5 per month in 2022, and 17 per month in both 2021 and 2020.
South Korea’s HLB Co. Ltd. saw its stock (KOSDAQ:028300) drop nearly 30% on May 17 as CEO Jin Yang-gon announced the U.S. FDA’s complete response letter (CRL) to its NDA seeking approval of its rivoceranib and camrelizumab (Airtuika, Jiangsu Hengrui Pharmaceutical Co. Ltd.) combo for liver cancer.
The U.S. FDA granted accelerated approval to Amgen Inc.’s Imdelltra (tarlatamab) for treating adults with extensive-stage small-cell lung cancer with disease progression on or after platinum-based chemotherapy. The approval may well lead the drug to blockbuster status while bolstering the company’s cancer portfolio.
Denver-based Arcscan Inc. gained Chinese approval of its computer-controlled, ultra-high frequency ultrasound diagnostic imaging solution for myopia called Insight 100, expanding its reach beyond the U.S. and Europe.
The U.S. FDA has several methods for signaling its enforcement intentions regarding medical devices and drugs, but there are times when warning letters are the vectors for communicating the agency’s current thinking.
The FTC’s request for a nearly 25% increase in funding for fiscal 2025 was splashed with cold water May 15 in a U.S. House Appropriations subcommittee hearing. That’s “a dramatic increase in funding for an agency whose work continues to raise concerns among many members of Congress and the public,” Rep. David Joyce (R-Ohio), chair of the Subcommittee on Financial Services and General Government, said as he opened the hearing.
The U.S. Centers for Medicare and Medicaid Services (CMS) is rethinking its proposed “stacking rule” for determining best price in the Medicaid program.
Citing the need to protect the public interest, the U.S. Department of Health and Human Services ordered an immediate government-wide funding suspension May 15 of Ecohealth Alliance Inc. while formal debarment proceedings are pending against the New York-based nongovernmental organization.
Following a cumbersome process, the U.S. FDA is withdrawing its accelerated approval for Truseltiq (infigratinib) as a second-line treatment for patients with unresectable locally advanced or metastatic cholangiocarcinoma harboring an FGFR2 fusion or rearrangement as detected by an FDA-approved test.
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