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7 小时
Nido Biosciences Announces Orphan Drug Designation for Lead Clinical Candidate to Treat ...
Nido Biosciences (Nido Bio), a clinical stage company developing precision medicines for debilitating neurological diseases, ...
hemophilianewstoday
17 小时
Committee recommends approval in EU of concizumab for hemophilia
A European Medicines Agency (EMA) committee has recommended the approval of Novo Nordisk’s concizumab as a prophylactic, or ...
Muscular Dystrophy News
5 小时
EMA agency continues to oppose renewing Translarna’s approval
CHMP upheld earlier opinions that Translarna is not of significant benefit to DMD due to nonsense mutations; European ...
Outsourcing-pharma
3 小时
PTC Therapeutics’ Translarna misses European regulatory hurdle again
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has once again snubbed Translarna ...
ALS News Today
5 小时
EMA’s CHMP upholds its negative opinion on masitinib for ALS
The opinion rejects granting conditional marketing authorization to AB Science’s masitinib as an oral add-on treatment for ALS in the EU.
The Pharma Letter
20 小时
Accord’s Stelara biosimilar Imuldosa wins positive CHMP recommendation
The fully-owned Intas Pharmaceuticals subsidiary Accord Healthcare has announced that the Committee for Medicinal Products ...
23 小时
ABIONYX Pharma Received Positive Feedback from the EMA for CER-001 in LCAT Deficiency
Regulatory News: ABIONYX Pharma, (FR0012616852 - ABNX - PEA PME eligible), a new generation biotech company dedicated to the ...
4 小时
on MSN
Success of long-lasting HIV drug hinges on pricing
Affordability and mass distribution will be critical to the success of a long-lasting injectable HIV prevention drug that has ...
14 小时
BeiGene receives positive CHMP opinions for tevimbra in gastric cancers
BeiGene (BGNE) announced that the Committee for Medicinal Products for Human Use – CHMP – of the European Medicines Agency issued ...
infectiousdiseaseadvisor.com
2 小时
Single COVID-19 mRNA Vaccine Dose Supported for Patients With Preexisting Immunity
A single COVID-19 mRNA vaccine dose provided similar protection to that conferred by a 2-dose series among immunocompetent ...
18 小时
Hold Rating for PTC Therapeutics Amidst Regulatory Hurdles with Translarna
Leerink Partners analyst Joseph Schwartz has maintained their neutral stance on PTCT stock, giving a Hold rating on October 11. Joseph ...
News Medical on MSN
16 小时
Affordability and supply remain critical to the success of long-lasting HIV drug
Affordability and mass distribution will be critical to the success of a long-lasting injectable HIV prevention drug that has ...
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