Blog
RSS FeedPosted by Michael Wonder on 22 Oct 2024
Camurus provides regulatory update on the US NDA for CAM2029 in acromegaly
22 October 2024 - The FDA issues a complete response letter for CAM2029 pending FDA’s assessment of responses from a third ...
Posted by Michael Wonder on 20 Oct 2024
Avadel Pharmaceuticals announces FDA approval of Lumryz (sodium oxybate) extended release oral suspension for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy
17 October 2024 - Granted orphan drug exclusivity in paediatric narcolepsy patients 7 years and older through 16 October 2031. ...
Posted by Michael Wonder on 19 Oct 2024
FDA approves zolbetuximab-clzb with chemotherapy for gastric or gastro-oesophageal junction adenocarcinoma
18 October 2024 - Today, the FDA approved zolbetuximab-clzb (Vyloy, Astellas Pharma), a claudin 18.2 (CLDN18.2) directed cytolytic antibody, with ...
Posted by Michael Wonder on 19 Oct 2024
Botox Cosmetic (onabotulinumtoxinA) receives FDA approval for moderate to severe vertical bands connecting the jaw and neck (platysma bands)
18 October 2024 - The only product of its kind approved for use in four aesthetic indications: temporary improvement in the ...
Posted by Michael Wonder on 18 Oct 2024
US FDA approves Vyalev (foscarbidopa and foslevodopa) for adults living with advanced Parkinson's disease
17 October 2024 - Adults treated with Vyalev reported superior improvement in "on" time without troublesome dyskinesia, compared to oral immediate-release ...
Posted by Michael Wonder on 14 Oct 2024
UCB receives US FDA approval for 320 mg single injection device presentations of Bimzelx (bimekizumab-bkzx)
14 October 2024 - The new pre-filled syringe and pre-filled auto-injector mean that patients requiring a 320 mg dose of ...
Posted by Michael Wonder on 13 Oct 2024
US FDA approves Dong-A ST’s Imuldosa (ustekinumab-srlf), a biosimilar to Stelara
11 October 2024 - Dong-A ST announced on October 11 2024 that Imuldosa (ustekinumab-srlf/DMB-3115), a biosimilar referencing Stelara, has won ...
Posted by Michael Wonder on 11 Oct 2024
FDA approves new treatment for haemophilia A or B
11 October 2024 - Product is first non-factor and once weekly treatment for haemophilia B. ...
Posted by Michael Wonder on 10 Oct 2024
FDA approves inavolisib with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer
10 October 2024 - Today, the FDA approved inavolisib (Itovebi, Genentech) with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, ...
Posted by Michael Wonder on 09 Oct 2024
Zealand Pharma provides US regulatory update on dasiglucagon in congenital hyperinsulinism
9 October 2024 - The re-inspection of the facility was completed in August/September 2024 for which a new inspection classification is ...
Posted by Michael Wonder on 09 Oct 2024
FDA approves use of up to three tubes of Biofrontera's Ameluz (aminolevulinic acid hydrochloride) 10% topical gel in one treatment
7 October 2024 - Supplemental new drug application supported by two Phase 1 safety studies. ...
Posted by Michael Wonder on 04 Oct 2024
FDA approves neo-adjuvant/adjuvant nivolumab for resectable non-small cell lung cancer
3 October 2024 - Today, the FDA approved nivolumab (Opdivo, Bristol Myers Squibb) with platinum-doublet chemotherapy as neo-adjuvant treatment, followed ...
Posted by Michael Wonder on 30 Sep 2024
Fresenius Kabi and Formycon receive US FDA approval for biosimilar Otulfi (ustekinumab-aauz)
30 September 2024 - In accordance with the patent settlement between Fresenius Kabi, Formycon and Johnson & Johnson, Fresenius Kabi has ...
Posted by Michael Wonder on 30 Sep 2024
FDA approves imaging drug for evaluation of myocardial ischaemia and infarction
27 September 2024 - The US FDA has approved Flyrcado (flurpiridaz F 18) in adult patients with known or suspected coronary ...
Posted by Michael Wonder on 29 Sep 2024
Dupixent (dupilumab) approved in the US as the first ever biologic medicine for patients with COPD
27 September 2024 - Following recent approvals in the EU and China, the US approval is based on two landmark Phase ...