Tuesday, January 28, 2020

Tuesday, January 28, 2020

Latest News

GILEAD: Submits Filgotinib New Drug Application to U.S. Food and Drug Administration Under Priority Review for Rheumatoid Arthritis Treatment

Gilead Sciences, Inc. (NASDAQ: GILD) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for filgotinib, an investigational, oral, selective JAK1 inhibitor for the treatment of adults who are living with moderate-to-severe rheumatoid arthritis (RA). A priority review voucher was submitted with the NDA, shortening the anticipated time for review.

PFIZER: U.S. FDA Accepts and Grants Priority Review to sNDA for BRAFTOVI® (encorafenib) in Combination with ERBITUX® (cetuximab) (BRAFTOVI Doublet) for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer After Prior Therapy

Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to the Company’s supplemental New Drug Application (sNDA) for BRAFTOVI® (encorafenib) in combination with ERBITUX® (cetuximab) (BRAFTOVI Doublet) based on results from the Phase 3 BEACON CRC trial, which evaluated the efficacy and safety of BRAFTOVI in combination with ERBITUX with or without MEKTOVI® (binimetinib) in patients with advanced BRAFV600E-mutant metastatic colorectal cancer (mCRC), following one or two lines of therapy.

3DBIO THERAPEUTICS: Receives FDA Rare Pediatric Disease Designation for AuriNovo™ for Ear Reconstruction in Microtia Patients

3DBio Therapeutics, an emerging leader in the field of 3D-bioprinting for human therapeutic use, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation for AuriNovo™, an investigational combination product for reconstruction of the outer ear in patients with microtia.

INNOVENT BIOLOGISTICS: Announces FDA Acceptance of NDA for Pemigatinib in Patients with Previously Treated, Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusions or Rearrangements

Innovent Biologics, Inc. ("Innovent" or "the Company") (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, announced that the new drug application ("NDA") submitted by Incyte to the U.S. Food and Drug Administration ("FDA") for pemigatinib in previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements has been accepted for Priority Review by FDA.

SFA THERAPEUTICS, INC.: Receives an FDA Orphan Drug Designation (ODD) for SFA001 in the Treatment of Hepatocellular Carcinoma (HCC)

SFA Therapeutics, Inc. announced today that FDA has granted an official Orphan Drug Designation (ODD) to SFA001, the company's novel human-microbiome-based treatment for human hepatocellular carcinoma (HCC).

U.S. FDA: Statement from Acting FDA Commissioner Ned Sharpless, M.D., and Center for Drug Evaluation and Research Director Janet Woodcock, M.D., on the agency's efforts to protect patients from potentially harmful drugs sold as homeopathic products

The U.S. Food and Drug Administration (FDA) recognizes that consumers may use various types of unapproved drugs, such as homeopathic drug products, to treat or relieve different diseases and conditions.

ENLIGHTENVUE: enlightenVue's Single Use Micro-Endoscope complies with new FDA recommendations to increase patient safety

The innovative micro-endoscope with multiple working channels is single use, eliminating the risk of transmitting infections among patients.

DURECT: Announces FDA Advisory Committee Meeting to Review POSIMIR® for the Treatment of Post-Surgical Pain

DURECT Corporation (Nasdaq: DRRX) announced that the U.S. Food and Drug Administration (FDA) has notified the Company that its Class 2 NDA resubmission for POSIMIR® (bupivacaine extended-release solution) will be discussed at a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC).

IPSEN: Announces FDA Approval of Dysport® (abobotulinumtoxinA) for the Treatment of Upper Limb Spasticity in Children, Excluding Cerebral Palsy

Dysport is the first and only FDA-approved botulinum toxin for treatment of both pediatric upper and lower limb spasticity

NOVO NORDISK: FDA approves Rybelsus® (semaglutide), the first GLP-1 analog treatment available in a pill for adults with type 2 diabetes

Rybelsus® represents an innovation in diabetes treatment by providing a GLP-1 receptor agonist in an oral formulation

U.S. FDA: FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma

The U.S. Food and Drug Administration is announcing Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE). Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners.

FDA Reporter