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RSS FeedPosted by Michael Wonder on 21 Jul 2021
Myovant Sciences announces European Commission approval for Ryeqo for the treatment of women with uterine fibroids
20 July 2021 - Ryeqo is the first and only once-daily long-term treatment for uterine fibroids in Europe. ...
Posted by Michael Wonder on 21 Jul 2021
EMA publishes agenda for 19-22 July CHMP meeting
19 July 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 21 Jul 2021
Venetoclax (Venclexta) granted US FDA breakthrough therapy designation in higher risk myelodysplastic syndrome
21 July 2021 - This is the sixth breakthrough therapy designation granted for venetoclax as AbbVie continues to show ongoing commitment ...
Posted 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 21 Jul 2021
New treatment authorised and available for Canadians with HER2 positive breast cancer
20 July 2021 - Phesgo, a fixed dose combination of pertuzumab and trastuzumab for subcutaneous injection combines two treatments into ...
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
EMA starts rolling review of COVID-19 vaccine Vidprevtyn
20 July 2021 - EMA’s CHMP has started a rolling review of Vidprevtyn, a COVID-19 vaccine developed by Sanofi Pasteur. ...
Posted 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, ...