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RSS FeedPosted by Michael Wonder on 16 May 2019
FDA approves first anticoagulant (blood thinner) for paediatric patients to treat potentially life-threatening blood clots
16 May 2019 - The U.S. FDA today approved Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of ...
Posted by Michael Wonder on 15 May 2019
Hospital drug making venture picks antibiotics as first products
15 May 2019 - Nonprofit Civica Rx plans to begin distributing vancomycin hydrochloride and daptomycin before the end of September. ...
Posted by Michael Wonder on 15 May 2019
Drug prices in TV ads: how transparent are they?
15 May 2019 - A website launched by pharmaceutical giant Eli Lilly earlier this year leads with a daunting statement ...
Posted by Michael Wonder on 15 May 2019
AbbVie announces US FDA approval of Venclexta (venetoclax) as a chemotherapy-free combination regimen for previously untreated chronic lymphocytic leukaemia patients
15 May 2019 - FDA reviewed the submission under the real-time oncology review pilot program. ...
Posted by Michael Wonder on 15 May 2019
Lipocine announces Tlando NDA PDUFA action date of 9 November 2019
14 May 2019 - Lipocine today announced that the U.S.FDA has accepted its new drug application for Tlando as testosterone ...
Posted by Michael Wonder on 15 May 2019
Homology Medicines announces FDA fast track designation for HMI-102 gene therapy development candidate for adults with PKU
14 May 2019 - Company provides details of pheNIX, the first gene therapy trial for PKU, and remains on track to ...
Posted by Michael Wonder on 15 May 2019
FDA approves Bavencio (avelumab) plus axitinib combination for patients with advanced renal cell carcinoma
14 May 2019 - Phase III study showed combination significantly lowered risk of disease progression or death by 31% and extended ...
Posted by Michael Wonder on 14 May 2019
A new study sparks a war of words over the drug industry’s commitment to research
14 May 2019 - The pharmaceutical industry spends about $1 in $5 of its revenues on research and development. ...
Posted by Michael Wonder on 14 May 2019
FDA approves Eylea (aflibercept) injection for diabetic retinopathy
13 May 2019 - Eylea improves diabetic retinopathy and prevents worsening disease that can lead to blindness. ...
Posted by Michael Wonder on 14 May 2019
FDA approves broadened indication for Xeomin (incobotulinumtoxinA) as first-line treatment for blepharospasm (involuntary blinking) in adult patients
13 May 2019 - Merz Americas announced today that the U.S. FDA has approved the supplemental biologics license application for Xeomin ...
Posted by Michael Wonder on 14 May 2019
Cellectar receives FDA fast track designation for CLR 131 in relapsed or refractory multiple myeloma
13 May 2019 - Designation could accelerate CLR 131 development and underscores the need for new treatments. ...
Posted by Michael Wonder on 14 May 2019
Celgene Corporation announces Pomalyst granted breakthrough therapy designation from FDA for HIV positive and negative Kaposi sarcoma
13 May 2019 - Celgene plans to submit sNDA by end of 2019. ...
Posted by Michael Wonder on 13 May 2019
Novartis pitches discounts on pricey gene therapy for deadly muscle disorder
11 May 2019 - Novartis is offering price discounts in negotiations with U.S. health insurers on its gene therapy for spinal ...
Posted by Michael Wonder on 13 May 2019
Considerations in demonstrating interchangeability with a reference product guidance for industry
9 May 2019 - This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable ...
Posted by Michael Wonder on 13 May 2019
Safety, efficacy, and quality remain top priorities as we continue our work to expand access to cost-saving generic drugs for the American public
13 May 2019 - Millions of Americans have difficulty paying for their prescription medications. ...