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Over the next two weeks, the U.S. Food and Drug Administration (FDA) has three upcoming decisions. Here’s a look.
Many of the big biopharma companies reported fourth-quarter and year-end earnings this week. If there’s a theme among them, it seems lower earnings per share are forecast for the year.
Potential New Indication Would Expand Use to Allow Treatment-Experienced Adults Living with HIV-1 Whose Virus is Suppressed to Switch to PIFELTRO (in Combination with Other Antiretrovirals) or DELSTRIGO
Nonalcoholic steatohepatitis (NASH) is prevalent in the U.S. and developing countries, but under that name, is largely unknown to the general public. NASH is a liver disease similar to cirrhosis, but which occurs in people who drink little or no alcohol.
The U.S. Food and Drug Administration (FDA) approved South Korea’s Samsung Bioepis’ Ontruzant (trastuzumab-dttb), a biosimilar to Genentech’s Herceptin (trastuzumab).
In 2018, the FDA approved 59 novel drugs, meaning approved new molecular entities. BioSpace analyzed new drug approvals from 2014 to 2018 to determine which companies were responsible for the most drug approvals in that period. Here’s a look.
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