Blog
RSS FeedPosted by Michael Wonder on 22 Oct 2024
CHMP recommends the approval of Dong-A ST’s Imuldosa, a biosimilar to Stelara
21 October 2024 - Dong-A ST announced on 18 October 2024 that its biosimilar Imuldosa (ustekinumab, development code DMB-3115), referencing ...
Posted by Michael Wonder on 22 Oct 2024
Highlights from the 14-17 October 2024 CHMP meeting
18 October 2024 - The CHMP recommended granting a marketing authorisation for Alhemo (concizumab), a medicine for routine prophylaxis of ...
Posted by Michael Wonder on 22 Oct 2024
Papillon Therapeutics receives rare paediatric disease designation from the US FDA for PPL-002 for the treatment of Danon disease
21 October 2024 - Papillon Therapeutics today announced that the US FDA has granted rare paediatric disease designation to Papillon’s PPL-002, ...
Posted by Michael Wonder on 21 Oct 2024
Protara Therapeutics granted FDA fast track designation for intravenous choline chloride for patients receiving parenteral support
21 October 2024 - Remain on track to initiate registrational THRIVE-3 trial in Q1, 2025. ...
Posted by Michael Wonder on 21 Oct 2024
Elevar Therapeutics announces FDA acceptance of new drug application resubmission for rivoceranib in combination with camrelizumab as a first-line systemic treatment for unresectable hepatocellular carcinoma
21 October 2024 - FDA sets a PDUFA target action date of 20 March 2025. ...
Posted by Michael Wonder on 21 Oct 2024
Gilead provides update on US indication for Trodelvy in metastatic urothelial cancer
18 October 2024 - Gilead Sciences today announced plans to voluntarily withdraw the US accelerated approval for Trodelvy (sacituzumab govitecan-hziy) for ...
Posted by Michael Wonder on 21 Oct 2024
Wainzua (eplontersen) recommended for approval in the EU by CHMP for the treatment of adult patients with polyneuropathy associated with hereditary transthyretin-mediated amyloidosis
21 October 2024 - Recommendation based on NEURO-TTRansform Phase 3 results showing Wainzua demonstrated consistent and sustained benefit improving neuropathy ...
Posted by Michael Wonder on 20 Oct 2024
Intercept provides regulatory update regarding sNDA for Ocaliva
17 October 2024 - Intercept Pharmaceuticals today announced that the US FDA has informed the Company that it is continuing its ...
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
Arcutis announces Health Canada approval of Zoryve (roflumilast) foam 0.3% to treat seborrheic dermatitis in individuals 9 years of age and older
18 October 2024 - Zoryve foam represents the first topical treatment for seborrheic dermatitis with a new mechanism of action approved ...
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
Alhemo recommended for European approval as first once daily subcutaneous prophylactic treatment for people living with haemophilia A or B with inhibitors
18 October 2024 - Novo Nordisk today announced that the EMA's CHMP has adopted a positive opinion, recommending approval of ...
Posted by Michael Wonder on 18 Oct 2024
Novartis receives positive CHMP opinion for Kisqali to help reduce risk of recurrence in people with HR+/HER2- early breast cancer
18 October 2024 - Recommendation is based on the Phase 3 NATALEE trial, where Kisqali added to endocrine therapy significantly reduced ...
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 ...