Drugs.com - New Drug Applications New drug applications news from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals.
- Pfizer and OPKO Provide Update on the Biologics License Application for Somatrogon for Pediatric Growth Hormone Deficiencyon January 21, 2022 at 12:01 am
NEW YORK & MIAMI--(BUSINESS WIRE) January 21, 2022 -- Pfizer Inc. (NYSE: PFE) and OPKO Health, Inc. (NASDAQ: OPK) announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the Biologics...
- Lexicon Submits New Drug Application for Sotagliflozin for the Treatment of Heart Failure in Adults with Type 2 Diabeteson December 30, 2021 at 11:12 pm
The Woodlands, Texas, December 30, 2021 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for the marketing and sale of...
- FDA Accepts Arcutis Biotherapeutics’ New Drug Application for Roflumilast Cream for Adults and Adolescents with Plaque Psoriasison December 22, 2021 at 9:12 pm
FDA has set a target action date of July 29, 2022 NDA supported by positive efficacy data from the pivotal Phase 3 DERMIS 1 and DERMIS 2 clinical studies, as well as results from the long-term safety study If approved, roflumilast cream would...
- Allarity Therapeutics Submits New Drug Application (NDA) to the U.S. FDA for Dovitinib for Third-Line Treatment of Renal Cell Carcinoma (RCC)on December 22, 2021 at 9:12 pm
Marks Allarity’s first regulatory application for marketing approval for one of its prioritized oncology pipeline programs NDA is supported by Allarity’s previously-filed pre-market approval (PMA) submission to the FDA for the...
- Takeda Receives Complete Response Letter from the U.S. FDA for TAK-721on December 21, 2021 at 11:12 pm
OSAKA, Japan, and CAMBRIDGE, Mass., December 21, 2021 – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug...
- Aquestive Therapeutics Receives Notification from FDA that It Will Not Be Ready to Take Action by December 23, 2021 for the Company’s NDA for Libervant™ (diazepam) Buccal Filmon December 20, 2021 at 9:12 pm
WARREN, N.J., Dec. 20, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic...
- Pfizer and BioNTech Submit Supplemental Biologics License Application for U.S. FDA Approval of Comirnaty in Adolescents 12 Through 15 Years of Ageon December 16, 2021 at 11:12 pm
NEW YORK and MAINZ, GERMANY, December 16, 2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to...
- Reata Pharmaceuticals Announces Outcome of FDA Advisory Committee Meeting of Bardoxolone for the Treatment of Patients with Chronic Kidney Disease Caused by Alport Syndromeon December 8, 2021 at 4:12 am
PLANO, Texas--(BUSINESS WIRE) December 8, 2021 -- Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the “Company,” or “we”), today announced the outcome of the U.S. Food and Drug Administration...
- Spectrum Pharmaceuticals Submits New Drug Application for Poziotinibon December 6, 2021 at 3:12 am
Fast Track application is based on positive data in NSCLC HER2 exon 20 insertion mutations in previously treated patients Positive Results for Cohort 2 of ZENITH20 clinical trial published in Journal of Clinical Oncology HENDERSON,...
- Secura Bio Announces Copiktra (duvelisib) Strategic Focus On T-cell Lymphoma And Voluntary U.S. Withdrawal Of The Relapsed Or Refractory Follicular Lymphoma Indicationon December 3, 2021 at 7:12 pm
SUMMERLIN, Nev., Dec. 3, 2021 /PRNewswire/ -- Secura Bio, Inc. (Secura Bio) - (www.securabio.com), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, has voluntarily...
- BeyondSpring Pharmaceuticals Receives Complete Response Letter from the FDA for Plinabulin New Drug Application for Prevention of Chemotherapy-Induced Neutropenia (CIN)on December 1, 2021 at 4:12 am
NEW YORK, Dec. 01, 2021 (GLOBE NEWSWIRE) -- BeyondSpring Pharmaceuticals (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global pharmaceutical company focused on the development of cancer therapeutics, today announced it...
- Secura Bio Announces U.S. Withdrawal of Farydak (panobinostat) NDAon November 30, 2021 at 4:11 am
SUMMERLIN, Nev., Nov. 30, 2021 /PRNewswire/ -- Secura Bio, Inc. (Secura Bio) - (www.securabio.com), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, announced today...
- Fennec Pharmaceuticals Expects to Receive Complete Response Letter from the FDA for its New Drug Application for Pedmark™ to Prevent Ototoxicity Associated with Cisplatin in Pediatric Patients with Localized, Non-Metastatic, Solid Tumorson November 29, 2021 at 9:11 pm
RESEARCH TRIANGLE PARK, N.C., November 29, 2021 – Fennec Pharmaceuticals Inc., a specialty pharmaceutical company, today announced that it expects to receive a Complete Response Letter (CRL) after the PDUFA target action date of November 27,...
- Verrica Pharmaceuticals Announces Resubmission of New Drug Application for VP-102 for the Treatment of Molluscum Contagiosumon November 29, 2021 at 4:11 am
WEST CHESTER, PA – November 29, 2021 (GLOBE NEWSWIRE) – Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions,...
- Obseva Announces U.S. FDA Acceptance of New Drug Application for Linzagolixon November 22, 2021 at 10:11 pm
GENEVA, Switzerland November 22, 2021 – Obseva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health,today announced that the New Drug Application...
- Gilead Submits Biologics License Application to U.S. Food and Drug Administration for Bulevirtide, an Investigational Treatment for People Living With Chronic Hepatitis Deltaon November 19, 2021 at 8:11 pm
If Approved, Bulevirtide Will Be the First Treatment Option for Adult Patients in the U. S. With Chronic Hepatitis Delta Virus Infection With Compensated Liver Disease FOSTER CITY, Calif.--(BUSINESS WIRE)--Nov. 19, 2021-- Gilead Sciences, Inc....
- Heron Therapeutics Announces Submission of HTX-019 NDA for the Prevention of Postoperative Nausea and Vomiting to FDAon November 18, 2021 at 8:11 pm
SAN DIEGO, Nov. 18, 2021 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet...
- FDA Grants Tentative Approval for Liquidia’s Yutrepia (treprostinil) Inhalation Powderon November 8, 2021 at 3:11 am
First dry-powder formulation of treprostinil to meet criteria required for FDA approval Final FDA approval may occur in October 2022 or earlier upon resolution of on-going litigation MORRISVILLE, N.C., Nov. 08, 2021 (GLOBE NEWSWIRE) --...
- Amylyx Pharmaceuticals Submits New Drug Application (NDA) for AMX0035 for the Treatment of ALSon November 2, 2021 at 3:11 am
CAMBRIDGE, Mass.–(BUSINESS WIRE)– November 2, 2021 -- Amylyx Pharmaceuticals, Inc. today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for AMX0035 (sodium phenylbutyrate (PB) and...
- Incyte Announces Acceptance of NDA for Parsaclisib for Three Types of Relapsed or Refractory Non-Hodgkin Lymphomason November 1, 2021 at 3:11 am
Priority Review granted to NDA for relapsed or refractory marginal zone lymphoma and mantle cell lymphoma Standard Review for NDA for relapsed or refractory follicular lymphoma WILMINGTON, Del.--(BUSINESS WIRE) November 1, 2021 -- Incyte...