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.

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.

GSK announced it received approval from the U.S. FDA’s Center for Biologics Evaluation and Research expanding the indication for FLUARIX QUADRIVALENT (Influenza Vaccine) to include use in persons 6 months and older.

Kyowa Hakko Kirin Co. Ltd. announced that the U.S. Food and Drug Administration has accepted for review the Biologics License Application for mogamulizumab to treat cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy, and has granted Priority Review status.