Musculo-skeletal disorder
BridgeBio Pharma shares positive feedback from FDA and EMA for phase 3 trial of infigratinib
September 7, 2023Research and Development BridgeBio Pharma, EMA, FDA, Musculo-skeletal disorder, achondroplasia, clinical trial
BridgeBio Pharma has announced positive feedback from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) on …
EC approves Roche’s Evrysdi for babies under two months with SMA
August 30, 2023Research and Development European Commission, Evrysdi, Musculo-skeletal disorder, Roche, spinal muscular atrophy
Roche has announced that the European Commission (EC) has approved the extension of Evrysdi’s marketing authorisation in the EU to …
Japan approves AstraZeneca’s Soliris for paediatric patients with gMG
August 24, 2023Medical Communications AstraZeneca, MHLW, Musculo-skeletal disorder, gMG, paediatric, soliris
AstraZeneca has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Soliris (eculizumab) for the extended use …
FDA approved Ipsen’s Sohonos capsules for treatment of fibrodysplasia ossificans progressiva
August 17, 2023Medical Communications FDA, FOP, Musculo-skeletal disorder, Sohonos, ipsen
Ipsen has announced that the US Food and Drug Administration (FDA) has approved Sohonos (palovarotene) capsules as a retinoid indicated …
MyMD reports statistically significant results from phase 2 trial for sarcopenia/age-related frailty
August 2, 2023Research and Development Musculo-skeletal disorder, MyMD, clinical trial, sarcopenia
MyMD Pharmaceuticals has announced statistically significant positive topline results from a phase 2 trial of oral TNF- α inhibitor, MYMD-1 …
Santhera closes exclusive license agreement with Catalyst Pharmaceuticals for Vamorolone
July 19, 2023Medical Communications License Agreement, Musculo-skeletal disorder, Vamorolone, catalyst, santhera
Santhera Pharmaceuticals has announced the closing of its exclusive North American license agreement for vamorolone with Catalyst Pharmaceuticals. The agreement …
Grünenthal receives FDA Breakthrough Therapy Designation for knee osteoarthritis drug
May 23, 2023Medical Communications Breakthrough Therapy Designation, FDA, Grunenthal, Musculo-skeletal disorder, osteoarthritis
German pharmaceutical company Grünenthal has announced that the US Food and Drug Administration (FDA) has awarded it Breakthrough Therapy Designation …
FDA pre-meeting report raises concerns over Sarepta’s gene therapy for Duchenne muscular dystrophy
May 11, 2023Medical Communications Duchenne Muscular Dystrophy, FDA, Musculo-skeletal disorder, Sarepta Therapeutics, gene therapy
The US Food and Drug Administration (FDA) has released a report in preparation for its 12 May decision on Sarepta …
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