New Drug Applications Archive - December 2020
December 1, 2020
- BridgeBio Pharma And Affiliate QED Therapeutics Announce FDA Acceptance Of New Drug Application For Infigratinib For The Treatment Of Cholangiocarcinoma
- TG Therapeutics Initiates Rolling Submission of Biologics License Application to U.S. Food and Drug Administration for Ublituximab in Combination with Umbralisib as a Treatment for Patients with Chronic Lymphocytic Leukemia
December 3, 2020
December 7, 2020
- Chimerix Announces FDA Acceptance of New Drug Application for Brincidofovir as a Medical Countermeasure for Smallpox
- Scynexis Announces FDA Acceptance and Priority Review of New Drug Application for Oral Ibrexafungerp for the Treatment of Vaginal Yeast Infections
- scPharmaceuticals Inc. Receives Complete Response Letter from FDA for Furoscix
- Sol-Gel Technologies Announces FDA Acceptance for Filing of New Drug Application for Twyneo for the Treatment of Acne Vulgaris
December 8, 2020
- Lipocine Announces Tentative Approval of TLANDO
- Albireo Submits for U.S. FDA and EMA Product Approval of Once-Daily Odevixibat for PFIC
December 10, 2020
December 15, 2020
December 18, 2020
December 21, 2020
December 23, 2020
- Verrica Pharmaceuticals Announces Resubmission of New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum
- Verrica Pharmaceuticals Announces Resubmission of New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum
December 28, 2020
- Chi-Med Initiates Rolling Submission of NDA to U.S. FDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors
- Cara Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for Korsuva Injection in Hemodialysis Patients with Moderate-to-Severe Pruritus
December 29, 2020
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