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Mallinckrodt gets two thumbs down from FDA for jaundice drug pharmafile
May 07, 2018
Mallinckrodt paid $80 million, with a further $345 million dependent on milestones, to acquire InfaCare in the hope that the latter’s treatment for jaundice in new-borns would gain a quick approval.
FDA approves Tafinlar/Mekinist for BRAF V600-mutant melanoma europeanpharmaceuticalreview
May 03, 2018
The FDA has approved Tafinlar in combination with Mekinist for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutation…
US priority review for Sanofi, Regeneron’s cemiplimab pharmatimes
May 03, 2018
US regulators are undertaking a priority review of Sanofi and Regeneron’s cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC)...
Novartis' CAR-T therapy gets second FDA approval pharmatimes
May 03, 2018
The FDA has approved Novartis' CAR-T therapy Kymriah (tisagenlecleucel) for intravenous infusion for its second indication - the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma ...
FDA grants Keytruda priority review pharmatimes
May 02, 2018
The FDA has accepted for review Merck & Co's anti-PD-1 therapy Keytruda in combination with Eli Lilly's Alimta (pemetrexed) and platinum chemotherapy ...
FDA grants orphan drug designation to elamipretide for LHON europeanpharmaceuticalreview
May 02, 2018
The FDA granted Orphan Drug Designation to elamipretide, for the treatment of Leber’s hereditary optic neuropathy…
FDA demand puts Compugen’s solid tumor checkpoint trial on ice fiercepharma
April 28, 2018
The FDA has temporarily blocked Compugen’s plans to start a phase 1 trial of PVRIG-targeting cancer drug COM701.
Alexion Pharmaceuticals to File for FDA Approval of Soliris Successor in Mid-2018 biospace
April 28, 2018
Alexion Pharmaceuticals closed out its first quarter plans to seek regulatory approval for its paroxysmal nocturnal hemoglobinuria (PNH) treatment, ALXN1210
FDA Warns of Serious Immune System Reaction with Lamotrigine americanpharmaceuticalreview
April 27, 2018
FDA is warning that the medicine lamotrigine (Lamictal) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body’s infection-fighting immune system.
Foundation Medicine’s New Liquid Biopsy Assay Granted Breakthrough Device Designation by U.S. Food and Drug Administration biospace
April 27, 2018
Foundation Medicine, Inc.today announced that the FDA granted a Breakthrough Device designation for its new liquid biopsy assay, which is an expanded version of its FoundationACT® assay.

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