Monday, March 30, 2020

Monday, March 30, 2020

Latest News

LEO PHARMA: Announces U.S. Food and Drug Administration (FDA) Expanded Regulatory Approvals for Enstilar® Foam and Taclonex® Topical Suspension in Treatment of Plaque Psoriasis

FDA approves Enstilar (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064%, for the topical treatment of plaque psoriasis in patients 12 years and older; Agency grants pediatric exclusivity extending U.S. market exclusivity

MCKESSON: NUBEQA® (darolutamide), FDA Approved for Treatment of High-Risk Non-Metastatic Prostate Cancer, Available at Biologics by McKesson

Biologics by McKesson, an independent specialty pharmacy for oncology and other complex therapeutic areas, was selected by Bayer HealthCare as a specialty pharmacy provider for NUBEQA® (darolutamide) for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC).

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves first therapy for rare joint tumor

The U.S. Food and Drug Administration granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery.

DAIICHI SANKYO: FDA Approves Daiichi Sankyo's TURALIO™ (pexidartinib) for the Treatment of Select Patients with TGCT, a Rare and Debilitating Tumor

TURALIO is the first and only approved therapy for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery

Phase 3 CANDLE study slated for Scynexis treatment of VVC

An agreement between pharmaceutical company Scynexis and the U.S. Food and Drug Administration (FDA) was reached under a special protocol assessment (SPA) on the details of the CANDLE (Conditions Affecting Neurocognitive Development and Learning in Early childhood) study for Oral Ibrexafungerp.

Curaleaf receives FDA letter about CBD product marketing

The leading vertically integrated multi-state cannabis operator in the U.S. issued a statement last week about a letter it received from the Food and Drug Administration (FDA) addressing the company's CBD product marketing.

Cannabis advocates urge FDA to ramp up CBD regulation

As the U.S. Food and Drug Administration (FDA) is being flooded with requests to allow CBD in food and supplements, marijuana advocacy groups are eager for federal regulators to monitor the marketplace to help establish some semblance of order.

CASAA condemns FDA's new anti-vaping ad campaign

President of the Board for The Consumer Advocates for Smoke-free Alternatives Association (CASAA) Bruce Nye compares the Food and Drug Administration’s (FDA) recent $60 million dollar anti-vaping television campaign to “propaganda” and “sloganeering.”

FOAMIX PHARMACEUTICALS: Foamix Submits New Drug Application to U.S. FDA for FMX103 for the Treatment of Moderate-to-Severe Papulopustular Rosacea

Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical therapies to address unmet needs in dermatology, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for FMX103 for the treatment of moderate-to-severe papulopustular rosacea in patients 18 years of age and older.

U.S. FOOD AND DRUG ADMINISTRATION: Statement on data accuracy issues with recently approved gene therapy

As a public health agency, we believe that it is critical to facilitate the development of innovative safe and effective medical products, like the cellular and gene therapy products that have shown enormous potential to treat previously untreatable diseases.

STOKE THERAPEUTICS: Granted FDA Orphan Drug Designation for STK-001, an Investigational New Treatment for Dravet Syndrome

Stoke Therapeutics, Inc., (Nasdaq: STOK), a biotechnology company pioneering a new way to treat the underlying cause of genetic diseases by precisely upregulating protein expression, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its lead product candidate, STK-001, an investigational new treatment for Dravet syndrome.

MCKESSON: TURALIO™ (pexidartinib), FDA Approved Treatment of TGCT, Available at Biologics by McKesson

Exclusive distribution agreement with Daiichi Sankyo, Inc. expands rare disease and complex therapeutic specialty pharmacy needs

FDA Update: July medical device recalls

Recalls of medical devices occur when a company sees a need to either take corrective action or remove a potentially hazardous device from the market, according to the U.S. Food and Drug Administration.

VESSELON: Acquires FDA-Approved Lipid Microsphere Drug Imagent® For Therapeutic Platform

Vesselon (www.vesselon.com), an oncology therapeutics company, announced the acquisition of an FDA-approved drug Imagent®. Vesselon will use Imagent to create novel therapeutic complexes in four classes of cancer drugs: cytokines, oncolytic viruses, monoclonal antibodies, and nucleic acid constructs.

BAUSCH HEALTH: Ortho Dermatologics Announces U.S. FDA Filing Acceptance For IDP-123 Treatment For Acne Vulgaris In Lotion Form

Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for IDP-123 (tazarotene 0.045%) Lotion with a PDUFA action date of Dec. 22, 2019.

FDA clears tests for new indications of Lyme disease

Diagnosing Lyme disease is notoriously difficult, so the announcement from the Food and Drug Administration (FDA) that four cleared tests with new indications are now cleared for marketing brings hope to the many who suffer from the disease.

FDA Health News