Jun 09, 2020
Coronavirus (COVID-19) Update: Daily Roundup
May 13, 2020
Arbor Pharmaceuticals Announces FDA Filing Acceptance of New Drug Application (NDA) for AR19, an Investigational ADHD Prescription Stimulant Treatment Specifically Designed to Resist Physical Manipulation for Nonmedical Misuse or Abuse
May 11, 2020
Coronavirus (COVID-19) Update: FDA Takes New Actions to Accelerate Development of Novel Prevention, Treatment Options for COVID-19
Apr 26, 2020
Halozyme Announces Janssen Submits New Drug Application In Japan For Daratumumab Subcutaneous Formulation Utilizing Halozyme's ENHANZE® Technology For Patients With Multiple Myeloma
Mar 26, 2020
Innocoll Holdings Limited Announces FDA Acceptance of New Drug Application for XARACOLL® for the Management of Postsurgical Pain after Open Inguinal Hernia Surgery
Feb 24, 2020
Lipocine Announces Regulatory Path Forward for TLANDO(TM) Resubmission
Feb 24, 2020
FDA approves first generic of ProAir HFA
Feb 20, 2020
Biostage Submitted Official Response to FDA for Investigational New Drug Application for its Lead Product Candidate Cellspan(TM) Esophageal Implant
Feb 19, 2020
Heron Therapeutics Announces FDA Extension of Review Period for NDA for HTX-011 for the Management of Postoperative Pain
Jan 17, 2020
DURECT Corporation Announces Outcome of FDA Advisory Committee Meeting for POSIMIR®
Jan 13, 2020
Blueprint Medicines Announces 2020 Corporate Goals
Dec 20, 2019
e5 Pharma Launches Generic Form of Diazoxide; Approved by FDA
Dec 03, 2019
Health Canada Grants Priority Review Status for Heron Therapeutics' New Drug Submission for HTX-011 for Management of Postoperative Pain
Nov 11, 2019
MabPlex Congratulates Encure Biopharma with FDA IND Clearance of YH001 for the Treatment of a Broad Range of Cancers
Nov 04, 2019
Former FDA and Regulatory Experts from Lachman Consultants, Inc., to Serve as Panelists at AAM GRx & Biosimilars Meeting
Oct 29, 2019
Digital submission of adverse event reports for investigational new drug applications reflects FDA's ongoing modernization efforts
Oct 28, 2019
Blueprint Medicines Announces FDA Intent to Split Avapritinib New Drug Application into Separate Submissions for PDGFRA Exon 18 Mutant GIST and Fourth-Line GIST
Oct 17, 2019
Foamix Announces FDA Acceptance of its New Drug Application for FMX103 Minocycline Foam for the Treatment of Moderate-to-Severe Papulopustular Rosacea
Oct 01, 2019
Heron Therapeutics Resubmits New Drug Application to FDA for HTX-011 for the Management of Postoperative Pain
Sep 30, 2019
LSNE Receives Approval To Manufacture Commercial Aseptic Generic Product At Its Recently Acquired Facility In León, Spain