Approvals
There’s been another milestone in the history of biotech: The world’s first RNAi gene-silencing drug, Alnylam Pharmaceuticals’ Onpattro, got approved on August 10. That makes 2018 a landmark year. But another year—2014—may prove just as influential for the field and how it develops.
Shire plc snagged approval from the U.S. Food and Drug Administration for Takhzyro (lanadelumab-flyo), a prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years of age and older.
The U.S. Food and Drug Administration (FDA) cleared Cleveland-based SPR Therapeutics’ SPRINT endura (single lead) and extensa (dual lead) Peripheral Nerve Stimulation (PNS) Systems for controlling pain.
The U.S. Food and Drug Administration (FDA) granted Merck & Co.’s Keytruda another approval, this one in combination with Alimta (pemetrexed) and platinum chemotherapy for first-line treatment of metastatic non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
It’s a busy week on the U.S. Food and Drug Administration (FDA)’s calendar, although the agency got ahead of itself and approved three of the applications early. Here’s a look.
The U.S. Food and Drug Administration has done another about-face. Days after rejecting Regeneron’s attempt to secure a supplemental approval for Eylea, the FDA has now approved a new dosing label for the drug in wet age-related macular degeneration (wet AMD).
The U.S. Food and Drug Administration (FDA) gave Bristol-Myers Squibb’s Opdivo (nivolumab) approval for metastatic small cell lung cancer (SCLC) for patients whose cancer has progressed after platinum-based chemotherapy and at least one other type of therapy.
Shares of Teva Pharmaceuticals jumped more than 7 percent in afternoon trading Thursday and continue to rise in premarket trading this morning after the U.S. Food and Drug Administration approved the company’s generic version of the EpiPen Auto-Injector.
Shares of Sun Pharmaceuticals have climbed more than 3 percent this morning after the U.S. Food and Drug Administration approved its dry eye treatment Cequa (cyclosporine ophthalmic solution) 0.09 percent.
This morning Genentech announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to Xolair to treat exposure to those deadly food allergies.
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