Record mula sa primary source
MateryalNaitakda ang petsa ng PDUFA
Gilead: Itinakda ng FDA ang petsa ng PDUFA sa Agosto 27, 2026 para sa NDA ng BIC/LEN
Tinanggap ng FDA ang NDA para sa BIC/LEN sa ilalim ng priority review. Nagtalaga ang ahensya ng PDUFA target action date na August 27, 2026, na nagtatatag ng regulatory timeline para sa single-tablet regimen na ito sa mga pasyenteng may HIV na virologically suppressed.
Mahahalagang fact
- Na-file
- May 7, 2026, 08:03 PM
- Kaganapan
- Naitakda ang petsa ng PDUFA
- Direksyon
- Neutral
- Kumpanya
GILDGilead- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- Kalendaryo
- Desisyon ng FDA (PDUFA) · Ago 27, 2026 · Walang naitalang resulta
Sipi mula sa source
EX-99.1 2 exhibit991earningspressrel.htm EXHIBIT 99.1 Document GILEAD SCIENCES ANNOUNCES FIRST QUARTER FINANCIAL RESULTS Product Sales Excluding Veklury Increased 8% Year-Over-Year to $6.8 billion Biktarvy Sales Increased 7% Year-Over-Year to $3.4 billion Foster City, CA, May 7, 2026 - Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the first quarter 2026. “Gilead teams have delivered another strong quarter with 8% year-over-year growth in our base business and 10% growth in HIV, supported by the successful launch of Yeztugo. We have raised our full year revenue guidance as a reflection of our performance," said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. “Building on the strongest pipeline in Gilead’s history, we are adding potentially
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Materyal
Abr 29, 2026
12:30 PM
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