CALA HEALTH: Receives FDA Breakthrough Device Designation for Cala Trio™ Therapy to Treat Action Tremors in Parkinson's Disease
Subsequent clinical trials expected to commence in 2020
Latest News
LEO PHARMA: Announces U.S. FDA Approval for Enstilar® (calcipotriene and betamethasone dipropionate) Foam U.S. Prescribing Information Update to Include Data in Long-term Use in Plaque Psoriasis Treatment
U.S. Prescribing Information (USPI) updated to include PSO-LONG clinical trial data concerning long-term use (52 weeks) of twice-weekly topical treatment with Enstilar® (calcipotriene and betamethasone dipropionate) Foam in adults with plaque psoriasis
AVIOQ: Announces FDA Approval of VioOne™ HIV Profile™ Supplemental Assay
Avioq, Inc. announces it has received approval from the U.S. Food and Drug Administration (FDA) for their VioOne™ HIV Profile™ Supplemental Assay.
BAYER: FDA Approves FoundationOne®CDx as Companion Diagnostic for Vitrakvi® (larotrectinib), to Aid in Identifying NTRK Fusion-Positive Patients
Detection of genomic alterations that drive the growth and spread of the tumor can guide treatment decisions for cancer therapies, including available biomarker driven treatments
EPIVAX: FDA Awards $1.1M Contract to CUBRC and EpiVax for Validation of New Immunoinformatic Tool for Prospective Immunogenicity Assessment of Peptide Drugs and Their Impurities
EpiVax and CUBRC announce $1.1M contract award from the OGD in CDER of the FDA in response to FDA BAA-20-00123.
EMBODY, INC.: Announces FDA 510(k) Clearance of TAPESTRY® Biointegrative Implant for Tendon and Ligament Repair
Embody, Inc., a privately-held medical device company developing novel collagen-based technologies for sports medicine and soft tissue repair, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its TAPESTRY Biointegrative Implant for tendon and ligament repair.
FDA: Approves First Treatment for COVID-19
U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization.
F2G: Receives Second US FDA Breakthrough Therapy Designation for Olorofim
In Phase 2b development for the treatment of life-threatening fungal infections
ABBVIE: Submits Regulatory Applications to FDA and EMA for RINVOQ™ (upadacitinib) in Atopic Dermatitis
In three pivotal Phase 3 studies, RINVOQ met co-primary and all secondary endpoints in adult and adolescent patients with moderate to severe atopic dermatitis
NEURELIS: Announces FDA Approval Of Extended Expiration Dating For VALTOCO® (Diazepam Nasal Spray)
Neurelis, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted extended expiration dating for the company's lead product, VALTOCO® (diazepam nasal spray).
FDA, Homeland Security Agencies Take Additional Action to Prevent Import of Illegal and Harmful Medical Products Through International Mail Facilities
The MOU will maximize inspection and detection capabilities in order to prevent this illegal activity.
FDA Publishes List of Essential Medicines, Medical Countermeasures, Critical Inputs Required by Executive Order
As the U.S. Food and Drug Administration continues our work to address the current pandemic, we are also looking ahead to prepare for the next potential public health emergency.