Mirum Pharmaceuticals Inc. followed September’s U.S. FDA approval of Atebrioz (zilurgisertib) in fibrodysplasia ossificans ...

Merck & Co. Inc. has added indifferent efficacy data to the safety signal seen in the top-line results of the phase IIb/III ...

Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions ...

Seven months after putting $920 million on the table for Aicuris Anti-infective Cures AG, Asahi Kasei Therapeutics Inc. has ...

Biopharma financings across all categories reached $90.21 billion in the first nine months of 2026, up 86% from $48.45 billion during the same period in 2025. The total marks the third-highest January ...

Over the entire mental health space, in the past 10 years, the FDA has approved 38 new drugs in a total of 48 indications. In Europe, three of those drugs are both approved and reimbursed in all five ...

Viatris Inc. plans to discuss the buyout of Pacira Biosciences Inc. during its third-quarter earnings call Nov. 5, but the ...

The drumbeat of innovation in the heart valves space continues as companies pursue next-generation devices for easier implantation, to improve durability and to treat younger patients. Even though ...

Huadong Medicine presented data for DD-1013, a novel long-acting GLP-1/GIP/amylin receptor triple agonist that was tested in vitro and in vivo for obesity management in diet-induced obese rats.

The FDA has awarded orphan drug designation to Vtv Therapeutics Inc.’s HPPD (HPP-8668), an investigational, oral, first-in-class Nrf2/Bach1 modulator, for sickle cell disease.

Ono Pharmaceutical Co. Ltd. is paying $100 million up front to gain select Asian rights to Biohaven Ltd.’s small-molecule IgG degrader portfolio, including in Japan, South Korea and Taiwan, as it ...

Worldwide drug approvals totaled 38 in August 2026, compared to 39 in August 2025 and 52 in August 2024. Through the first eight months of 2026, global approvals totaled 337, down 6.4% from 360 during ...