US rejects MSD/Eisai’s Keytruda Lenvima combo
Regulators rejected accelerated approval as Roche’s combination for the same patient population made it over the line first
Read Moreby Selina McKee | Jul 9, 2020 | News | 0
Regulators rejected accelerated approval as Roche’s combination for the same patient population made it over the line first
Read Moreby Selina McKee | Dec 23, 2019 | News | 0
US regulators have declined ViiV Healthcare’s application to market an investigational long-acting regimen for the treatment of HIV
Read Moreby Selina McKee | Dec 12, 2018 | News | 0
Mallinckrodt’s SpecGx division has announced the rejection of its abuse-deterrent re-formulation of opioid analgesic Roxicodone by the US Food and Drug Administration (FDA).
Read Moreby Selina McKee | Sep 20, 2018 | News | 0
US regulators have turned down Pharming’s application to expand the approved uses of Ruconest to include prophylaxis in patients with hereditary angioedema (HAE).
Read Moreby Selina McKee | Sep 10, 2018 | News | 0
GlaxoSmithKline’s bid to expand the use of its biologic Nucala in the US to include patients with coronary pulmonary obstructive disorder (COPD) has hit a significant setback.
Read Moreby Selina McKee | Sep 3, 2018 | News | 0
Sunovion’s application to market dasotraline for the treatment of attention-deficit hyperactivity disorder (ADHD) has been rejected by US regulators.
Read Moreby Selina McKee | Aug 28, 2018 | News | 0
US regulators have rejected Akcea/Ionis’ application to market Waylivra for the ultra-rare rare lipid disorder familial chylomicronemia syndrome (FCS).
Read Moreby Selina McKee | Jun 19, 2018 | News | 0
The US Food and Drug Administration has rejected Valeant group Ortho Dermatologics’ plaque psoriasis therapy Duobrii.
Read Moreby Selina McKee | Jun 14, 2018 | News | 0
Mylan has announced that US regulators are going to reject its generic version of GlaxoSmithKline’s asthma/COPD inhaler Advair Diskus.
Read Moreby Selina McKee | May 10, 2018 | News | 0
US regulators have rejected Lipocine’s Tlando, a testosterone replacement therapy for adult males with hypogonadism.
Read Moreby Selina McKee | Oct 26, 2017 | News | 0
PTC Therapeutics will need to carry out at least one further trial to demonstrate the effectiveness of its Duchenne Muscular Dystrophy therapy Translarna if it is to have a chance of bagging its approval in the US.
Read Moreby Selina McKee | Aug 7, 2017 | News | 0
The US Food and Drug Administration has rejected Vernalis’ cough cold treatment CCP-08, which is being developed by US partner Tris Pharma.
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