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SOFTWAVE® TISSUE REGENERATION TECHNOLOGIES: Receives FDA Clearance for the Treatment of Burn Wounds

SoftWave® Tissue Regeneration Technologies, a disruptive bio-medical device company, was cleared by the FDA on Friday, Aug. 28, 2020, for the treatment of superficial, partial-thickness, second-degree burns in adults (FDA 510k letter number K200926).

FDA: Approves First-of-its-Kind Automated Insulin Delivery and Monitoring System for Use in Young Pediatric Patients

The U.S. Food and Drug Administration approved the MiniMed 770G System, a hybrid closed loop diabetes management device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses with little or no input from the users or their caregivers for use by individuals aged 2 to 6 with type 1 diabetes.

BEARPAC MEDICAL: Announces Commercial Launch of the New Passio Pump Drainage System After Receiving FDA 510(k) Clearance

Bearpac Medical, LLC is pleased to announce that they have launched a new FDA 510(k) cleared device intended to treat patients with malignant and other recurrent pleural effusions.

PTC THERAPEUTICS: Announces First Commercial Milestone Payment Following U.S. FDA Approval of Evrysdi™ (risdiplam)

PTC Therapeutics, Inc. (NASDAQ: PTCT) announced that the company achieved a $20 million milestone payment from Roche under its License and Collaboration Agreement.

RECORDATI RARE DISEASES INC.: U.S. FDA Approves CYSTADROPS® (Cysteamine Ophthalmic Solution) 0.37%, A New Practical Treatment Option for the Ocular Manifestations of Cystinosis

Recordati Rare Diseases Inc., announced the U.S. Food and Drug Administration (FDA) has approved CYSTADROPS® (cysteamine ophthalmic solution) 0.37%. CYSTADROPS is a new, viscous eye drop solution that depletes corneal cystine crystal deposits in people living with cystinosis.

JANSSEN: U.S. FDA Approves New DARZALEX® (daratumumab)-Based Combination Regimen for Patients with Relapsed/Refractory Multiple Myeloma

Approval broadens DARZALEX label to include fifth treatment option in the relapsed/refractory setting and represents the eighth approved indication for DARZALEX

NOVARTIS PHARMACEUTICALS CORPORATION: FDA approves Novartis Kesimpta® (ofatumumab), the first and only self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis

Kesimpta delivers powerful efficacy with a favorable safety profile and can be self-administered at home, addressing significant unmet needs for people living with relapsing forms of multiple sclerosis (RMS)

23ANDME: Granted New FDA Clearance to Provide Interpretive Drug Information for Two Commonly Prescribed Medications

510(k) Clearance allows 23andMe to report interpretive drug information for medications prescribed for heart conditions and depression without the need for confirmatory testing

FDA: Approves Treatment for Rare Disease Affecting Optic Nerves, Spinal Cord

Third FDA-Approved Therapy in Just Over a Year for Neuromyelitis Optica Spectrum Disorder Gives Patients Another Treatment Option

RAPIDAI: Receives FDA Clearance of Rapid LVO For Identification of Suspected Large Vessel Occlusions

RapidAI, the worldwide leader in advanced imaging for stroke, today announced that Rapid LVO has received Food and Drug Administration (FDA) clearance for detecting suspected LVOs (Large Vessel Occlusions).

BAYER: FDA Approves Gadavist® (gadobutrol) Imaging Bulk Package

The first and only FDA-approved gadolinium-based contrast agent for multi-patient dosing with an FDA-cleared Transfer Spike in the MR suite.

FDA: Approves Oral Treatment for Spinal Muscular Atrophy

The U.S. Food and Drug Administration approved Evrysdi (risdiplam) to treat patients two months of age and older with spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting muscle strength and movement.

VIIV HEALTHCARE: Announces FDA approval of an expanded indication for Dovato (dolutegravir/lamivudine), a complete two-drug regimen for virologically suppressed adults with HIV-1

Dovato allows adults living with HIV to reduce the number of antiretroviral therapies they take each day, while maintaining efficacy and high barrier to resistance comparable to tenofovir-based regimens of at least three drugs

BAYER: U.S. Food and Drug Administration Approves Lampit® (nifurtimox) for the Treatment of Chagas Disease in Children

Only Chagas disease treatment approved in U.S. for use in children from birth to less than 18 years of age

GENENTECH: ADDING MULTIMEDIA FDA Approves Genentech’s Evrysdi (risdiplam) for Treatment of Spinal Muscular Atrophy (SMA) in Adults and Children 2 Months and Older

In two clinical trials, Evrysdi improved motor function in people living with SMA over a broad spectrum of ages and levels of disease severity, including Types 1, 2, and 3 SMA

FDA Health News