Early access and regulation

Another lost decade for research?
Another lost decade for research? What does the patent landscape look like for antibiotics, vaccines and orphan drugs?
First von Willebrand disease therapy heads new FDA approvals
First von Willebrand disease therapy heads new FDA approvals Baxalta's Vonvendi set for an early 2016 launch in the US
Wakix backed for European approval in narcolepsy
Wakix backed for European approval in narcolepsy Bioprojet Pharma’s orphan drug given a positive opinion by CHMP
FDA grants Tocagen’s glioblastoma drug orphan status
FDA grants Tocagen’s glioblastoma drug orphan status Puts the brain cancer gene therapy in-line for development incentives
Sobi wins European approval for oral form of orphan drug Orfadin
Sobi wins European approval for oral form of orphan drug Orfadin Expandstreatment options for rare genetic disease HT-1
Sanofi gains accelerated review for rare disease drug
Sanofi gains accelerated review for rare disease drug New pill for Fabry disease could be approved by the FDA before the end of the year
AstraZeneca gains FDA orphan status for new cancer drug
AstraZeneca gains FDA orphan status for new cancer drug Gains a longer patent life for the investigational lung disease drug
Eisai’s thyroid cancer drug Lenvima nears EU approval
Eisai’s thyroid cancer drug Lenvima nears EU approval Positive recommendation by the CHMP could see the orphan drug used in Europe within three months
FDA grants orphan drug status to Treeway's ALS treatment
FDA grants orphan drug status to Treeway's ALS treatment Amyotrophic Lateral Sclerosis drug TW001 gainsregulatory benefits
FDA clears first therapy for rare childhood cancer
FDA clears first therapy for rare childhood cancer United Therapeutics’ Unituxin approved for neuroblastoma
Jinarc backed for European approval in rare kidney disease
Jinarc backed for European approval in rare kidney disease Positive opinion for Otsuka comes just before rare disease awareness day
Europe gains access to first stem cell drug
Europe gains access to first stem cell drug Chiesi's Holoclar has been given the green light for a rare eye condition
Imbruvica gets FDA OK for rare lymphoma
Imbruvica gets FDA OK for rare lymphoma Cancer drug available in US to treat Waldenström's macroglobulinaemia          
NICE backs first ‘ultra-orphan’ drug Soliris
NICE backs first ‘ultra-orphan’ drug Soliris Final guidance backs Alexion’s treatment for very rare blood clot condition
FDA approves Ipsen drug to treat rare tumours
FDA approves Ipsen drug to treat rare tumours Green light for Somatuline Depot in cancer of the neuroendocrine system
Celgene wins orphan drug award at PMEA
Celgene wins orphan drug award at PMEA Company is recognised for providing early access to Imnovid in multiple myeloma
FDA approves Baxter drug for rare form of haemophilia
FDA approves Baxter drug for rare form of haemophilia Obizur is derived from pig proteins
Janssen's blood cancer drug Imbruvica approved in Europe
Janssen's blood cancer drug Imbruvica approved in Europe European commission licenses the first-in-class drug for two rare diseases
Boehringer's Ofev approved by FDA for rare lung disease
Boehringer's Ofev approved by FDA for rare lung disease US regulator also gives the green light to Intermune's Esbriet
FDA awards $19m in rare disease grants
FDA awards $19m in rare disease grants US regulator supports 15 orphan drug projects

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