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U.S. FDA: Approves first generics of Gilenya
The U.S. Food and Drug Administration has approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients.
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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.
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.
EPIZYME: Submits New Drug Application to the U.S. FDA for Tazemetostat for the Treatment of Patients with Follicular Lymphoma
Submission Marks On-time Execution of Second NDA Submission for Tazemetostat in 2019
UROGEN PHARMA: Announces FDA Filing Acceptance and Priority Review of U.S. New Drug Application (NDA) for UGN-101
Potential for UGN 101 to be First Non-Surgical Therapy for the Treatment of Low-Grade Upper Tract Urothelial Cancer (LG UTUC)
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.
FORWARD SCIENCE: Receives FDA Clearance for Orapeutic for Opioid Free Oral Pain Management
Forward Science received FDA Clearance for OrapeuticTM, a non-opioid oral pain relief gel. Forward Science is a MedTech company that operates R&D, its quality system, manufacturing, sales and support all from its Worldwide headquarters in Houston, TX.
SUNOVION: Announces FDA Filing Acceptance of Resubmitted New Drug Application for Apomorphine Sublingual Film
Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for apomorphine sublingual film (APL-130277) to treat motor fluctuations (OFF episodes) experienced by people living with Parkinson’s disease (PD), which was resubmitted on November 21, 2019. The expected action date by the FDA under the Prescription Drug User Fee Act (PDUFA) is May 21, 2020.
ASTELLAS: FDA Grants Accelerated Approval to Astellas’ and Seattle Genetics’ PADCEV™ (enfortumab vedotin-ejfv) for People with Locally Advanced or Metastatic Urothelial Cancer, the Most Common Type of Bladder Cancer
First-in-Class Antibody-Drug Conjugate Directed Against Nectin-4, a Protein Highly Expressed in Urothelial Tumors
DAIICHI-SANKYO: ENHERTU® Approved in the U.S. for HER2 Positive Unresectable or Metastatic Breast Cancer Following Two or More Prior Anti-HER2-Based Regimens
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved ENHERTU® (fam-trastuzumab deruxtecan-nxki), a HER2 directed antibody drug conjugate (ADC), for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.
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MERCK: Announces FDA Approval for ERVEBO® (Ebola Zaire Vaccine, Live)
Action Represents Another Milestone for the Global Partnership Against Ebola
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VIIV HEALTHCARE: Receives complete response letter from US FDA for use of investigational cabotegravir and rilpivirine long-acting regimen in the treatment of HIV
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its application for cabotegravir and rilpivirine long-acting regimen for treatment of HIV-1 infection in virologically suppressed adults.
INTERSCOPE: Announces new FDA Clearance of the EndoRotor®, for use in Airway procedures including in Interventional Pulmonology
Interscope, Inc. announced today the receipt of marketing clearance from the FDA for the EndoRotor® System to commercialize Pulmonary indications.
SOLITON: Announces Successful Completion of Safety Testing at SGS to Support FDA Filing for Second Generation Device
Soliton, Inc., (Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center ("MD Anderson"), announced its Rapid Acoustic Pulse ("RAP") device successfully completed the IEC 60601 safety testing being conducted at SGS, the world's leading inspection, verification, testing and certification company. The testing was led by a team at Sanmina Corporation, a leading electronics manufacturing services provider.
VERO BIOTECH: Receives US FDA Approval of GENOSYL® for the Delivery of Inhaled Nitric Oxide
The GENOSYL® inhaled nitric oxide approval represents the first and only FDA-approved tankless delivery system and is an important new development in the clinical application of inhaled nitric oxide
JANSSEN PHARMACEUTICAL COMPANIES OF JOHNSON & JOHNSON: Complete Response Letter Issued from U.S. FDA for Investigational Long-Acting HIV Regimen
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) in response to ViiV Healthcare's (ViiV) New Drug Application for the two-drug long-acting (LA) injectable regimen of ViiV's cabotegravir and Janssen's rilpivirine for the treatment of HIV-1 infection in adults. The regimen was co-developed as part of a collaboration between Janssen and ViiV.