FDA Approvals
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FDA Grants Breakthrough Therapy Designation for Genentech’s TECENTRIQ in Combination With Avastin as First-Line Treatment for Advanced or Metastatic Hepatocellular Carcinoma (HCC)
7/18/2018
Genentech announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for TECENTRIQ® (atezolizumab)
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RDD Pharma Announces IND Clearance to Advance RDD-0315 to Treat Fecal Incontinence in Patients with Spinal Cord Injury
7/17/2018
The IND was filed in the US on May 30, 2018.
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Candela Announces FDA Clearance Of Vbeam® Prima
7/17/2018
The new Vbeam Prima takes Candela's "gold standard" 595 nm Pulsed Dye Laser (PDL) platform to the next level
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FDA Clears First Nanotechnology Peek Devices for Spinal Intervertebral Fusion
7/17/2018
Vallum Corporation Receives FDA Clearance for Its PEEKplus® Nanotexturing
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Janssen Announces U.S. FDA Approval of SYMTUZA™ (D/C/F/TAF), the First and Only Complete Darunavir-Based Single-Tablet Regimen for the Treatment of HIV-1 Infection
7/17/2018
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S FDA has approved SYMTUZA™, the first and only complete, darunavir-based single-tablet regimen (STR) for the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment-naïve and certain virologically suppressed adults.
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Inozyme Pharma Receives Orphan Drug Designation for INZ-701 in the United States and European Union
7/17/2018
Novel Enzyme Replacement Therapy in Development for Treatment of ENPP1 Deficiency
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Gamida Cell Receives Orphan Drug Designation from the FDA for NiCord® as a Treatment for Hematopoietic Stem Cell Transplantation
7/17/2018
Gamida Cell announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for NiCord as a treatment for hematopoietic stem cell transplantation (HSCT).
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Zavation Announces 510(k) Clearance of the Normandy VBR System (Cervical and Thoracolumbar Expandable Corpectomy Cage)
7/17/2018
Zavation announced today that it has received 510(k) clearance from the FDA to market Normandy VBR System (Cervical and Thoracolumbar Expandable Corpectomy Cage).
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The U.S. Food and Drug Administration (FDA) was busy during the first half of this year with more than 20 novel drug approvals. Of those approvals, one-third came in June.
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Shares of Siga Technologies soared more than 11 percent late Friday after the company announced that its smallpox treatment Tpoxx was approved by the U.S. Food and Drug Administration.
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July can be a notoriously slow period for FDA activity, and this year is no different. There are only five PDUFA dates scheduled for the month, and the first one was a supplemental approval for Merck’s Keytruda. The PDUFA date was July 3, but it was approved June 13. At this point in the month th...
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Four months after filing a supplemental New Drug Application with the U.S. Food and Drug Administration, Astellas and Pfizer snagged regulatory approval for Xtandi as a treatment for non-metastatic Castration-Resistant Prostate Cancer (CRPC).
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MaxCyte Receives US FDA Investigational New Drug Clearance for First Clinical Program
7/16/2018
Company to conduct Phase I clinical study of MCY-M11, a CAR therapeutic, in patients with ovarian cancer and peritoneal mesothelioma
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Quidel Receives FDA Clearance for Solana® Bordetella Complete® Molecular Diagnostic Assay for the Detection of Pertussis (Whooping Cough), Parapertussis Infections
7/16/2018
Quidel Corporation announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market its Solana Bordetella Complete Assay
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FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity
7/13/2018
The U.S. Food and Drug Administration (FDA) is alerting health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure.
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FDA approves the first drug with an indication for treatment of smallpox
7/13/2018
The U.S. Food and Drug Administration today approved TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox.
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U.S. FDA Approves XTANDI® (enzalutamide) for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer (CRPC)
7/13/2018
First and Only Oral Treatment FDA-Approved for Both Non-Metastatic and Metastatic CRPC
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Roche PCT assay cleared for expanded use - Important tool in antibiotic resistance crisis
7/13/2018
Elecsys® B·R·A·H·M·S PCT™ (procalcitonin) helps clinicians assess presence and severity of certain bacterial infections and patient response to antibiotics
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The U.S. Drug Enforcement Agency is in the midst of readdressing cannabis following the regulatory approval of the first cannabinoid-based drug for the treatment of some epilepsy patients.
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On June 11, 2018, FDA Commissioner Scott Gottlieb released a complementary framework for gene therapies, noting that in the last 12 months the agency has approved three different gene therapy products. “This reflects the rapid advancements in this field,” Gottlieb stated.