Food and Drug Administration (FDA)
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Shares of Adamis Pharmaceuticals are down nearly 5 percent this morning after the company announced late Tuesday that the U.S. Food and Drug Administration rejected its sublingual tadalafil product for erectile dysfunction, an alternative to the blockbuster Cialis.
FDA Commissioner Scott Gottlieb said the agency has changed its approach to the opioid crisis and will take a more aggressive approach on regulatory actions.
Shares of Karyopharm Therapeutics are crashing again after an advisory panel from the U.S. Food and Drug Administration recommended delaying potential approval of the company’s experimental multiple myeloma treatment until additional data is available from an ongoing Phase III study.
FDA Approval Allows Interventional Cardiologists Access to Resolute DES Technology to Treat De Novo CTO
In addition to its fourth-quarter financial report, Morris Plains, NJ-based Immunomedics announced that its president, chief executive officer and board member, Michael Pehl, was stepping down for personal reasons.
Roche’s Flatiron Health and the U.S. Food and Drug Administration’s Information Exchange and Data Transformation (INFORMED) Program expanded a two-year-old collaboration agreement.
The FDA noted some concerns over the drug’s safety profile. Treatment with selinexor is associated with significant toxicity, the agency noted in its materials.
Significant milestone toward the commercialization of eptinezumab, the first quarterly infusion therapy for migraine prevention
Pfizer’s blockbuster rheumatoid arthritis drug Xeljanz, a JAK inhibitor, has been a strong performer for the company, bringing in $1.77 billion in revenue last year. But now the company has indicated it intends to make a change in its post-marketing study due to safety concerns.
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