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RSS FeedPosted by Michael Wonder on 20 Jul 2021
Kyowa Kirin announces EU approval for the self administration of Crysvita (burosumab) to treat X-linked hypophosphataemia
19 July 2021 - An additional option is now available to healthcare professionals to meet the needs of X-linked hypophosphataemia patients and ...
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
Albireo receives European marketing authorisation of Bylvay (odevixibat), the first drug treatment for progressive familial intrahepatic cholestasis
19 July 2021 - First approval in the world of Bylvay for the treatment of progressive familial intrahepatic cholestasis. ...
Posted by Michael Wonder on 20 Jul 2021
Streamlining proprietary ingredient categories
20 July 2021 - To help make the medicines application process more efficient, the TGA no longer allocates proprietary ingredient ...
Posted by Michael Wonder on 20 Jul 2021
Clinical trial national approach will benefit patients and our economy
20 July 2021 - Medicines Australia welcomes the clinical trial ‘one-stop-shop’ consultation, recently announced by the Australian Commission on Safety ...
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 20 Jul 2021
Almirall receives European Commission approval of Klisyri (tirbanibulin), an innovative topical treatment for actinic keratosis
19 July 2021 - Klisyri (tirbanibulin) is a topical first in class microtubule inhibitor indicated for the treatment of actinic keratosis ...
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
EMA starts evaluating the use of Kineret in adult COVID-19 patients at increased risk of severe respiratory failure
19 July 2021 - EMA has started evaluating an application to extend the use of Kineret (anakinra) to include treatment ...