Endo International plc submitted a Biologics License Application to the U.S. Food and Drug Administration for collagenase clostridium histolyticum (CCH) for the treatment of cellulite in the buttocks.
Morris Plains, N.J.-based Immunomedics announced that the company’s president, chief executive officer and board member, Michael Pehl, was stepping down for personal reasons.
The U.S. Food and Drug Administration gave Janssen Biotech and the Johnson & Johnson company’s research partner Genmab an approval for their Darzalex split-dosing regimen.
The U.S. Food and Drug Administration placed Princeton, N.J.-based Advaxis’ Phase III clinical trial of axalimogene filolisbac (AXAL) in advanced cervical cancer on partial clinical hold.
2018 was a record year for biotech initial public offerings (IPOs), but 2019 is off to a slow and rocky start because of the government shutdown.
Merck received FDA approval for new indications for the PARP inhibitor Lynparza – which is jointly developed and commercialized by AstraZeneca – and the checkpoint inhibitor Keytruda.
Despite winning regulatory approval for a copycat version of Copaxone earlier in 2018, Cambridge, Mass.-based Momenta Pharmaceuticals completed a strategic review that includes slashing staff by 50 percent as the company focuses resources on two biosimilar candidates in the pipeline.
Roche said the U.S. FDA extended by three months the review period for Tecentriq in combination therapy as a first-line treatment for a form of lung cancer.
Regeneron Pharmaceuticals announced positive top-line data from the Phase III PANORAMA study of Eylea (aflibercept) injection in moderately severe to severe non-proliferative diabetic retinopathy.
FDA Accepts for Filing Supplemental Biologics License Application for Xeomin in Adult Patients with Sialorrhea
Merz North America announced today that the U.S. Food and Drug Administration accepted for filing a supplemental Biologics License Application for Xeomin (incobotulinumtoxinA) for the treatment of chronic sialorrhea (excessive drooling) due to Parkinson’s Disease or other neurologic disorders in adult patients.