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RSS FeedPosted by Michael Wonder on 09 Sep 2019
Reeling from scandal, Novartis vows to voluntarily release info on manipulated data in the future
9 September 2019 - Seeking to appease angry regulators, Novartis committed to notifying the FDA within five business days of ...
Posted by Michael Wonder on 07 Sep 2019
FDA approves first treatment for patients with rare type of lung disease
6 September 2019 - The U.S. FDA today approved Ofev (nintedanib) capsules to slow the rate of decline in pulmonary ...
Posted by Michael Wonder on 03 Sep 2019
Mylan and Biocon get a second complete response letter for insulin glargine follow-on
3 September 2019 - Over the weekend, drug maker Biocon disclosed that it and partner Mylan have been issued a second ...
Posted by Michael Wonder on 29 Aug 2019
U.S. FDA approves Mylan generic of Lilly lung cancer drug Alimta
29 August 2019 - The U.S. Food and Drug Administration on Thursday granted Mylan tentative approval for its generic version ...
Posted by Michael Wonder on 27 Aug 2019
FDA approves new add-on drug to treat off episodes in adults with Parkinson's disease
27 August 2019 - The U.S. FDA today approved Nourianz (istradefylline) tablets as an add-on treatment to levodopa/carbidopa in adult patients ...
Posted by Michael Wonder on 27 Aug 2019
Akorn receives FDA approval for azelastine hydrochloride 0.15% nasal spray
26 August 2019 - Akorn today announced that it received a new Abbreviated new drug application approval from the U.S. FDA ...
Posted by Michael Wonder on 26 Aug 2019
FDA approves US WorldMeds' Myobloc (rimabotulinumtoxinB) injection for chronic sialorrhea
26 August 2019 - Myobloc is the only approved botulinum toxin for chronic sialorrhoea that provides significant results in as early ...
Posted by Michael Wonder on 26 Aug 2019
Lilly receives U.S. FDA approval for Taltz (ixekizumab) for the treatment of active ankylosing spondylitis (radiographic axial spondyloarthritis)
26 August 2019 - Eli Lilly and Company announced today that the U.S. FDA has approved Taltz (ixekizumab) injection 80 ...
Posted by Michael Wonder on 25 Aug 2019
Time for FDA to release complete responses letters? Debate reignites.
23 August 2019 - The idea of the US FDA releasing complete response letters resurfaced this week as Sarepta Therapeutics ...
Posted by Michael Wonder on 20 Aug 2019
Sarepta Therapeutics receives complete response letter from the US FDA for golodirsen new drug application
19 August 2019 - Sarepta Therapeutics today announced it had received a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 20 Aug 2019
Vanda Pharmaceuticals FDA update for Hetlioz in the treatment of jet lag disorder
19 August 2019 - Vanda Pharmaceuticals today announced that on 16 August 2019, it received a complete response letter from ...
Posted by Michael Wonder on 19 Aug 2019
FDA approves new antibiotic to treat community-acquired bacterial pneumonia
19 August 2019 - The U.S. FDA today approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia. ...
Posted by Michael Wonder on 18 Aug 2019
Roche drug approval offers a glimpse at the future of cancer treatment
15 August 2019 - The FDA on Thursday approved Roche’s cancer drug Rozlytrek for patients with any kind of tumour ...
Posted by Michael Wonder on 16 Aug 2019
FDA approves treatment for patients with rare bone marrow disorder
16 August 2019 - Today, the U.S. Food and Drug Administration approved Inrebic (fedratinib) capsules to treat adult patients with ...
Posted by Michael Wonder on 16 Aug 2019
AbbVie receives FDA approval of Rinvoq (upadacitinib), an oral JAK inhibitor for the treatment of moderate to severe rheumatoid arthritis
16 August 2019 - Approval supported by efficacy and safety data from one of the largest registrational Phase 3 programs in ...