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The FDA has approved the first-ever generic of AbbVie’s 20-year-old immunomodulator Restasis for dry eye — Mylan Pharmaceuticals’ cyclosporine ophthalmic emulsion 0.05 percent single-use vials. Read More
At the FDA’s request, Pfizer and partner BioNTech have asked the agency to expand their Emergency Use Authorization (EUA) for the Comirnaty COVID-19 vaccine to include a two-shot series for children six months to four years old. Read More
The FDA has approved Roche’s Vabysmo (faricimab-svoa) for treating the two most common forms of vision loss, paving the way for the drug to go head-to-head with Regeneron Pharmaceuticals’ blockbuster, Eylea (aflibercept). Read More
The European Medicines Agency’s (EMA) human medicines committee endorsed seven drugs for new indications during its monthly meeting last week, including Pfizer’s highly effective COVID-19 antiviral Paxlovid (nirmatrelvir and ritonavir). Read More
Regeneron Pharmaceuticals and Sanofi are pulling their supplemental Biologics License Application (sBLA) for the indication of cervical cancer for their human monoclonal antibody, Libtayo (cemiplimab-rwlc). Read More
Immunocore’s Kimmtrak (tebentafusp-tebn) has won FDA approval for treating inoperable or metastatic uveal melanoma, a rare adult eye cancer with poor prognosis. Read More
Fiscal 2022 is already setting a dismal pace for generic drug approvals, which sunk to a record low last year under the full brunt of COVID-19 supply-chain and clinical trial interruptions. Read More