Blog
RSS FeedPosted by Michael Wonder on 21 Jul 2021
U.S. FDA expands indication for Prograf for prevention of organ rejection in adult and paediatric lung transplant recipients
21 July 2021 - Prograf becomes first immunosuppressive drug approved in the U.S. for people receiving a lung transplant. ...
Posted by Michael Wonder on 20 Jul 2021
Albireo announces FDA approval of Bylvay (odevixibat), the first drug treatment for patients with progressive familial intrahepatic cholestasis
20 July 2021 - Commercial launch of Bylvay immediate; available for prescription in the coming days. ...
Posted by Michael Wonder on 20 Jul 2021
NeuroMetrix receives FDA breakthrough device designation for treatment of fibromyalgia with its wearable neurostimulation technology
20 July 2021 - NeuroMetrix today announced that its Quell device has received breakthrough designation from the U.S. FDA for treating ...
Posted by Michael Wonder on 20 Jul 2021
FDA approves Octapharma’s Octagam 10% for adult dermatomyositis
20 July 2021 - FDA approval based on positive results of international, multi-center ProDERM study. ...
Posted by Michael Wonder on 20 Jul 2021
US FDA approves fexinidazole as the first all oral treatment for sleeping sickness
19 July 2021 - US FDA approves fexinidazole as the first all-oral treatment for sleeping sickness. ...
Posted by Michael Wonder on 20 Jul 2021
Ardelyx provides regulatory update on new drug application for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis
19 July 2021 - Ardelyx today announced that it received a letter from the U.S. FDA on 13 July 2021, ...
Posted by Michael Wonder on 19 Jul 2021
Foundation Medicine expands indication for FoundationOne Liquid CDx to be used as a companion diagnostic for Tabrecta (capmatinib)
15 July 2021 - Tabrecta is the first FDA approved MET inhibitor for patients with metastatic non-small cell lung cancer with ...
Posted by Michael Wonder on 19 Jul 2021
Nevro announces FDA approval of its 10 kHz high frequency spinal cord stimulation therapy for treatment of chronic pain associated with painful diabetic neuropathy
19 July 2021 - HFX for painful diabetic neuropathy now the only spinal cord stimulation system approved by FDA to treat ...
Posted by Michael Wonder on 19 Jul 2021
Endologix receives FDA breakthrough device designation for ChEVAS system
19 July 2021 - Investigational EVAS system designed for patients with complex abdominal aortic aneurysm. ...
Posted by Michael Wonder on 19 Jul 2021
Aquestive Therapeutics announces FDA acceptance of new drug application resubmission for Libervant (diazepam) buccal film
19 July 2021 - Prescription Drug User Fee Act target goal date set for 23 December 2021. ...
Posted by Michael Wonder on 19 Jul 2021
G1 Therapeutics receives fast track designation from U.S. Food and Drug Administration for Cosela (trilaciclib) in combination with chemotherapy for the treatment of locally advanced or metastatic triple negative breast cancer
19 July 2021 - G1 Therapeutics today announced that the U.S. FDA has granted fast track designation to Cosela (trilaciclib) ...
Posted by Michael Wonder on 19 Jul 2021
BlueRock Therapeutics receives FDA fast track designation for DA01 in the treatment of advanced Parkinson’s disease
19 July 2021 - BlueRock Therapeutics announced that the U.S. FDA has granted fast track designation for DA01 for advanced Parkinson’s ...
Posted by Michael Wonder on 19 Jul 2021
Making sense of the FDA’s ‘indefensible’ decision to approve Aduhelm
19 July 2021 - There are three sides to every story that defies logic: the defenders’ side, the critics’ side and ...
Posted by Michael Wonder on 19 Jul 2021
Lilly and Incyte provide update on supplemental new drug application for baricitinib for the treatment of moderate to severe atopic dermatitis
16 July 2021 - Eli Lilly and Incyte announced today that the U.S. FDA will not meet the Prescription Drug User ...
Posted by Michael Wonder on 19 Jul 2021
AbbVie provides update regarding Rinvoq (upadacitinib) for the treatment of moderate to severe atopic dermatitis in the U.S.
16 July 2021 - AbbVie today announced the U.S. FDA did not meet the Prescription Drug User Fee Act action ...