Aspirin

JUVÉDERM® VOLUMA® XC For Temple Hollows Receives U.S. FDA Approval

Retrieved on: 
Tuesday, March 5, 2024

IRVINE, Calif., March 5, 2024 /PRNewswire/ -- Today, Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced the U.S. FDA approval of JUVÉDERM® VOLUMA® XC for injection in the temple region to improve moderate to severe temple hollowing in adults over the age of 21.1 JUVÉDERM® VOLUMA® XC is the first and only hyaluronic acid (HA) dermal filler to receive U.S. FDA approval for the improvement of moderate to severe temple hollowing with results lasting up to 13 months with optimal treatment.*1

Key Points: 
  • *1
    "The approval of JUVÉDERM® VOLUMA® XC to treat temple hollows further demonstrates Allergan Aesthetics commitment to innovation and addressing patient needs," said Carrie Strom, President, Allergan Aesthetics and Senior Vice President, AbbVie.
  • "This is the first U.S. FDA approval of a hyaluronic acid dermal filler for use in the upper face and addresses a real unmet need for patients."
  • The safety of JUVÉDERM® VOLUMA® XC in patients with a history of excessive scarring or pigmentation disorders has not been studied.
  • To report a side effect with any product in the JUVÉDERM® Collection, please call the Allergan® Product Support Department at 1‑877‑345‑5372.

FDA Approves First Medication to Treat Severe Frostbite

Retrieved on: 
Wednesday, February 14, 2024

SILVER SPRING, Md., Feb. 14, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation.

Key Points: 
  • SILVER SPRING, Md., Feb. 14, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation.
  • Frostbite can occur in several stages, ranging from mild frostbite that does not require medical intervention and does not cause permanent skin damage, to severe frostbite when both the skin and underlying tissue are frozen and blood flow is stopped, sometimes requiring amputation.
  • Iloprost's efficacy in treating severe frostbite was primarily established in an open-label, controlled trial that randomized 47 adults with severe frostbite, who all received aspirin by vein and standard of care, into one of three treatment groups.
  • The two other groups received other medications that are unapproved for frostbite, given with iloprost (Group 2) or without iloprost (Group 3).

Nalu Bio and PIPA Bring Cannabinoid Combinations To CPG Brands in First-Of-Its-Kind Partnership Powered by AI

Retrieved on: 
Thursday, February 8, 2024

SAN FRANCISCO, Feb. 8, 2024 /PRNewswire/ -- Nalu Bio, a biotech company specializing in no-high, chemistry-derived cannabinoids to address the top health and wellness challenges, today announced a first-of-its-kind partnership with PIPA, AI leader in Nutrition, Health and Wellness innovation to bring AI-enabled combinations of cannabinoids and bioactives to consumer packaged goods (CPG) companies. This partnership aims to create a new category of products at a time when market demand, cultural acceptance, and desire for cannabinoids are on the rise around the world.

Key Points: 
  • Nalu Bio is the first company to offer combinations of cannabinoids and bioactives to address pain, anxiety, sleep, and weight management.
  • According to Nutrition Business Journal's 2023 Supplement Report, combination sales are expected to surpass single ingredient supplement sales this year.
  • In tandem with PIPA, Nalu Bio will leverage predictive AI modeling to identify the optimal combinations of cannabinoids with unique bioactives such as vitamins, protein, fiber, antioxidants, probiotics, and superfoods.
  • Like vitamins, not only can chemically-derived cannabinoid combinations address multiple health needs, but they can scale responsibly, safely, and sustainably.

Premier Diversified Holdings Inc. Announces Cease Trade Order and Provides Update on the Proposed Acquisition of AJA Health and Wellness Ltd., Assured Diagnosis Inc., and AJA Therapeutics Inc.

Retrieved on: 
Monday, February 5, 2024

VANCOUVER, British Columbia, Feb. 05, 2024 (GLOBE NEWSWIRE) -- Premier Diversified Holdings Inc. ("PDH" or the "Company") (TSXV:PDH) announces that further to the press release dated January 18, 2024, whereby the Company announced the filing of an application seeking a management cease trade order (“MCTO”) from the British Columbia Securities Commission (“BCSC”) due to its inability to file its annual financial statements for the year ending September 30, 2023 including the related management’s discussion and analysis and certifications from the CEO and CFO (the “Annual Filings”), the BCSC will issue a cease trade order against PDH (the “CTO”).

Key Points: 
  • The Corporation continues to pursue the acquisitions of AJA Health and Wellness Ltd. ("AJA Health"), AJA Therapeutics Inc. ("ATI"), and Assured Diagnosis Inc. ("ADI", and together with PDH, AJA Health, and ATI, the "Parties").
  • The Acquisition, subject to certain conditions and applicable shareholder and regulatory approvals, will result in a reverse takeover of PDH.
  • There can be no assurance that the Acquisition will be completed as proposed or at all.
  • AJA Health and ADI are diligently working on having audits completed on their financial statements.

Heron Therapeutics Announces FDA Approval of ZYNRELEF® Indication Expansion to Include Additional Orthopedic and Soft Tissue Procedures

Retrieved on: 
Wednesday, January 24, 2024

SAN DIEGO, Jan. 23, 2024 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company, today announced that the U.S. Food and Drug Administration (the "FDA") has approved its supplemental New Drug Application ("NDA") for ZYNRELEF® (bupivacaine and meloxicam) extended-release solution to expand the indication for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. ZYNRELEF was previously approved for foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures in adults.

Key Points: 
  • ZYNRELEF was previously approved for foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures in adults.
  • This expanded indication for ZYNRELEF will now cover an estimated 13 million procedures annually, an estimated increase of 86% over prior indicated procedures.
  • To obtain this labeling expansion, Heron successfully conducted studies for cesarean section, spinal surgery, augmentation mammoplasty, and total shoulder arthroplasty.
  • The most common side effects of ZYNRELEF are soft tissue procedures: vomiting and orthopedic procedures: constipation and headache.

Human medicines European public assessment report (EPAR): Clopidogrel Krka, clopidogrel, Date of authorisation: 23/09/2009, Revision: 19, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Clopidogrel Krka, clopidogrel, Date of authorisation: 23/09/2009, Revision: 19, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Clopidogrel Krka, clopidogrel, Date of authorisation: 23/09/2009, Revision: 19, Status: Authorised

Human medicines European public assessment report (EPAR): Inhixa, enoxaparin sodium, Date of authorisation: 15/09/2016, Revision: 26, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Inhixa, enoxaparin sodium, Date of authorisation: 15/09/2016, Revision: 26, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Inhixa, enoxaparin sodium, Date of authorisation: 15/09/2016, Revision: 26, Status: Authorised

Human medicines European public assessment report (EPAR): Rivaroxaban Viatris (previously Rivaroxaban Mylan), rivaroxaban, Date of authorisation: 12/11/2021, Revision: 5, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Rivaroxaban Viatris (previously Rivaroxaban Mylan), rivaroxaban, Date of authorisation: 12/11/2021, Revision: 5, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Rivaroxaban Viatris (previously Rivaroxaban Mylan), rivaroxaban, Date of authorisation: 12/11/2021, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Clopidogrel Taw Pharma (previously Clopidogrel Mylan), clopidogrel, Date of authorisation: 21/09/2009, Revision: 21, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Clopidogrel Taw Pharma (previously Clopidogrel Mylan), clopidogrel, Date of authorisation: 21/09/2009, Revision: 21, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Clopidogrel Taw Pharma (previously Clopidogrel Mylan), clopidogrel, Date of authorisation: 21/09/2009, Revision: 21, Status: Authorised

Human medicines European public assessment report (EPAR): Clopidogrel Viatris (previously Clopidogrel Taw Pharma), clopidogrel, Date of authorisation: 16/10/2009, Revision: 27, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Clopidogrel Viatris (previously Clopidogrel Taw Pharma), clopidogrel, Date of authorisation: 16/10/2009, Revision: 27, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Clopidogrel Viatris (previously Clopidogrel Taw Pharma), clopidogrel, Date of authorisation: 16/10/2009, Revision: 27, Status: Authorised