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  1. NASDAQ: GILD) Type of Application: sNDA Candidate: Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets) Indication: Pre-exposure prophylaxis, or PrEP, for HIV-1 infection Date ...

  2. Pfizer Inc. PFE announced that its investigational oral JAK1 inhibitor abrocitinib has met all co-primary and key secondary endpoints in the second pivotal phase III study (B7451013). The double-blind ...

  3. Drugmakers over the last two years raised prices on seven widely used medications above the rate of medical inflation and without any new clinical evidence to justify the increases, according ...

  4. The 52-week phase III study FINCH 1 evaluated filgotinib compared to AbbVie's ABBV Humira (adalimumab) or placebo on a stable background dose of methotrexate (MTX) in patients with prior inadequate ...

  5. Karen Walker, a veteran of more than 20 years of global technology industry marketing, will join Intel as senior vice president and chief marketing officer (CMO), effective Oct. 23. Walker will ...

  6. Notwithstanding the ESMO conference generating some huge moves in some stocks, last week turned out to be a muted one for biotechs. A few FDA approvals came through, with Puma Biotechnology ...

  7. Verastem's (VSTM) Copiktra Gets Orphan Drug Designation

    Zacks via Yahoo FinanceOct 08 14:02 PM

    Verastem, Inc. VSTM announced that the FDA has granted orphan drug designation to Copiktra (duvelisib) for the treatment of T-Cell lymphoma. The drug already enjoys Fast Track designation for this indication.

  8. The company is evaluating IPI-549 as a monotherapy and in combination with Bristol-Myers Squibb's BMY Opdivo in a phase I/Ib study (MARIO-1) in about 200 patients with advanced solid tumors.

  9. Lilly Gets FDA Approval for New Oral Tablets for Migraine

    Zacks via Yahoo FinanceOct 14 14:14 PM

    Eli Lilly & Company LLY announced that the FDA has approved lasmiditan for the treatment of acute migraine headaches, with or without aura, in adults. Lasmiditan, an oral 5-HT1F ...

  10. Dermira, Inc. DERM announced that it has started dosing in a phase III study, evaluating its monoclonal antibody candidate, lebrikizumab, in patients with moderate-to-severe atopic dermatitis ...

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