Category - New Drug Applications

New Drug Applications

FDA Accepts Genentech’s Biologics License Application for Fixed-Dose Subcutaneous Combination of Perjeta And Herceptin For HER2-Positive Breast Cancer

5 years ago

New Drug Applications

NDA Accepted for Filing by the FDA for Antisense Oligonucleotide Viltolarsen (NS-065/NCNP-01)

5 years ago

New Drug Applications

Trevena Resubmits New Drug Application for Oliceridine

5 years ago

New Drug Applications

Deciphera Pharmaceuticals Announces U.S. Food And Drug Administration Acceptance Of New Drug Application And Priority Review For Ripretinib In Patients With Advanced Gastrointestinal Stromal Tumors

5 years ago

New Drug Applications

PharmaMar and Jazz Pharmaceuticals Announce FDA Acceptance and Priority Review of New Drug Application for Lurbinectedin in Relapsed Small Cell Lung Cancer

5 years ago

New Drug Applications

Heron Therapeutics Announces FDA Extension of Review Period for NDA for HTX-011 for the Management of Postoperative Pain

5 years ago

New Drug Applications

FDA Accepts BioCryst’s NDA for Oral, Once Daily Berotralstat (BCX7353) to Prevent HAE Attacks

5 years ago

New Drug Applications

U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol-Myers Squibb’s Biologics License Application (BLA) for Lisocabtagene Maraleucel (liso-cel) for Adult Patients with Relapsed or Refractory Large B-Cell Lymphoma

5 years ago

New Drug Applications

MorphoSys Announces Submission of Biologics License Application for Tafasitamab in r/r DLBCL to the FDA

5 years ago

New Drug Applications

TG Therapeutics Initiates Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Umbralisib as a Treatment for Patients with Previously Treated Marginal Zone Lymphoma or Follicular Lymphoma

5 years ago