Stimlabs LLC received U.S. FDA approval for Corplex P, a wound care product that uses placental tissue to facilitate wound healing. “Corplex P is the first particulate device derived from human umbilical cord extracellular matrix indicated for the management of acute and chronic wounds,” Stimlabs CEO John Daniel told BioWorld.
The U.S. FDA has approved Duvyzat (givinostat), from Italfarmaco SpA, for treating Duchenne muscular dystrophy (DMD). It is the first oral, nonsteroidal drug for treating all of DMD’s genetic variants. The oral treatment is approved for those ages 6 and older.
Vertex Pharmaceuticals Inc. has obtained IND clearance from the FDA for VX-407, an investigational first-in-class small-molecule corrector that targets the underlying cause of autosomal dominant polycystic kidney disease (ADPKD) in patients with a subset of PKD1 genetic variants.
Kevin Dills, who the U.S. SEC said secretly controlled Oncology Pharma Inc., consented to a final civil judgment in federal district court related to a fraudulent stock-selling scheme.
The U.S. FDA’s pending final rule for regulation of lab-developed tests has proven unusually controversial even for the FDA, but Rep. Anna Eshoo (D-Calif.) stated in a March 21 hearing that congressional inaction has left the agency in an uncomfortable spot.
An advocate general (AG) for the E.U. Court of Justice did not mince words in calling out the European Commission for its “very significant extension of the scope of the Merger Regulation and of the commission’s jurisdiction” in reviewing Illumina Inc.’s $7.1 billion acquisition of Grail LLC.
CSPC Pharmaceutical Group Ltd. has obtained clearance by China’s National Medical Products Administration (NMPA) to conduct clinical trials in China with SYS-6023 for advanced solid tumors.
As part of its required series of guidances on using real-world evidence, the U.S. FDA released a draft guidance in response to sponsors’ growing interest in the potential use of observational studies to contribute to a demonstration of the effectiveness or safety of a drug or biologic.
Although there’s bipartisan interest in the U.S. Congress to hold pharmacy benefit managers (PBMs) accountable for their contribution to the costliest drug prices in the world, the Biden administration ignored PBMs when it again focused on drug companies as the bad guys of pricing in its proposed 2025 budget.
After months of wrangling, the update of the EU pharmaceutical legislation passed an important milestone on March 19, when members of parliament on the health committee reconciled their opposing views and voted the file through.
RSS
