The U.S. FDA’s Center for Biologics Evaluation and Research posted four warning letters to makers of HIV sample collection kits, an example of a shift in FDA enforcement in the IVD space that is still allowed after a historical loss in court.
The U.S. FDA’s device center posted a report on the TAP program, stating that the metrics available to date suggest the program is a rousing success. Still, there are a few key indicators that have not yet had time to emerge – such as product approvals and clearances, but those data points won’t emerge for another year or two at the inside.
After selling off amyotrophic lateral sclerosis therapeutics last month, Tanabe Pharma America Inc. emerged a forerunner in another rare disease space with positive top-line phase III data of dersimelagon (MT-7117) for erythropoietic protoporphyria/X-linked protoporphyria.
1st Biotherapeutics Inc. announced the closing of a ₩31.7 billion series D funding round Jan. 26 to advance its lead phase I oncology asset, FB-849, and portfolio of candidates for neurodegenerative diseases.
The U.S. FDA approved 27 drugs in December, the highest month of 2025. This compares to 18 approvals in November and brings the full year total to 226. This places 2025 just below the 228 approvals recorded in 2024 but well above approval numbers seen in most prior years of the past decade.
1st Biotherapeutics Inc. announced the closing of a ₩31.7 billion series D funding round Jan. 26 to advance its lead phase I oncology asset, FB-849, and portfolio of candidates for neurodegenerative diseases.
Insilico Medicine Cayman Topco has obtained IND approval from the FDA for ISM-8969 for the treatment of Parkinson’s disease, enabling initiation of a phase I trial in healthy volunteers.
The FDA’s Center for Devices and Radiological Health posted two important guidances just in the first week of the new year. The agency seems determined to sustain that pace with a new draft guidance for cuffless blood pressure monitors, apparently in response to sales of unauthorized over-the-counter devices for this indication.
Alveus Therapeutics Inc. has obtained IND clearance from the FDA for ALV-100, for chronic weight management, enabling initiation of a phase Ib study. Dosing has now commenced in the study.
Lexicon Pharmaceuticals Inc. announced that it received no objections from the U.S. FDA to move pilavapadin, its non-opioid candidate for diabetic peripheral neuropathic pain, into phase III study, pushing company shares up near 20% on the day.
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