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RSS FeedPosted by Michael Wonder on 29 Sep 2023
Appili Therapeutics announces US FDA approval of Likmez (ATI-1501) metronidazole oral suspension
25 September 2023 - Currently Likmez is the only liquid oral suspension of metronidazole approved in the US. ...
Posted by Michael Wonder on 28 Sep 2023
Amicus Therapeutics announces FDA approval and launch of new treatment for Pompe disease
28 September 2023 - Pombiliti (cipaglucosidase alfa-atga) + Opfolda (miglustat) approved in ERT experienced adults. ...
Posted by Michael Wonder on 28 Sep 2023
US FDA approves subcutaneous administration of Takeda's Entyvio (vedolizumab) for maintenance therapy in moderately to severely active ulcerative colitis
27 September 2023 - Entyvio is the only FDA approved ulcerative colitis biologic that offers the choice of intravenous or ...
Posted by Michael Wonder on 28 Sep 2023
Botanix Pharmaceuticals suffers setback in FDA approval for sofpironium bromide gel to treat hyperhidrosis
26 September 2023 - Botanix Pharmaceuticals has had its application to use the novel sofpironium bromide gel to treat primary ...
Posted by Michael Wonder on 27 Sep 2023
Ocuphire Pharma and Viatris announce FDA approval of Ryzumvi (phentolamine ophthalmic solution) 0.75% eye drops for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents
27 September 2023 - Ryzumvi expected to be commercially available in the US in the first half of 2024. ...
Posted by Michael Wonder on 25 Sep 2023
FDA issues complete response letter for Udencya Onbody biologics license application solely due to an on-going review of inspection findings at a third-party filler
25 September 2023 - No issues with clinical efficacy or safety, trial design, labeling, drug substance manufacturing, or device design or ...
Posted by Michael Wonder on 24 Sep 2023
US FDA approves Jardiance for the treatment of adults with chronic kidney disease
22 September 2023 - Jardiance (empagliflozin) 10 mg tablets significantly reduced the risk of kidney disease progression and cardiovascular death in ...
Posted by Michael Wonder on 20 Sep 2023
FDA issues complete response letter for neffy (epinephrine nasal spray) new drug application with request for additional study
19 September 2023 - FDA Advisory Committee (PADAC), held in May 2023, recommended neffy approval based on current data set and ...
Posted by Michael Wonder on 18 Sep 2023
Australian made cancer drug gets billion dollar US FDA approval
19 September 2023 - A drug invented in Melbourne to treat a lethal bone marrow cancer is set to become ...
Posted by Michael Wonder on 17 Sep 2023
Ojjaara (momelotinib) approved in the US as the first and only treatment indicated for myelofibrosis patients with anaemia
15 September 2023 - Approval is for use in myelofibrosis patients with anaemia regardless of prior myelofibrosis therapy. ...
Posted by Michael Wonder on 14 Sep 2023
FDA approves new and updated indications for temozolomide under Project Renewal
14 September 2023 - Today, the FDA approved updated labelling for temozolomide (Temodar, Merck) under Project Renewal, an Oncology Center ...
Posted by Michael Wonder on 11 Sep 2023
FDA takes action on updated mRNA COVID-19 vaccines to better protect against currently circulating variants
11 September 2023 - Today, the US FDA took action approving and authorising for emergency use updated COVID-19 vaccines formulated to ...
Posted by Michael Wonder on 11 Sep 2023
BioLineRx announces FDA approval of Aphexda (motixafortide) in combination with filgrastim to mobilise haematopoietic stem cells for collection and subsequent autologous transplantation in patients with multiple myeloma
11 September 2023 - Aphexda is the first innovation in stem cell mobilisation for multiple myeloma to be approved in the ...
Posted by Michael Wonder on 06 Sep 2023
Update on US regulatory review of Ultomiris in NMOSD
6 September 2023 - The US FDA has issued a complete response letter regarding the supplemental biologics license application for ...
Posted by Michael Wonder on 30 Aug 2023
Outlook Therapeutics provides regulatory update on FDA review of ONS-5010 / Lytenava (bevacizumab-vikg) for the treatment of wet AMD
30 August 2023 - FDA issues complete response letter for ONS-5010 biologics license application based on CMC and need for further ...