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Acadia Pharma Stock Plummets After FDA Head Tells Congress Parkinson’s Drug Under Investigation biospace
April 27, 2018
Acadia Pharmaceuticals shares dropped 22 percent yesterday after U.S. Food and Drug Administration (FDA) commissioner Scott Gottlieb told Congress the agency would investigate the company’s Nuplazid.
FDA authorises new use of test to identify the emerging pathogen Candida auris europeanpharmaceuticalreview
April 26, 2018
The FDA has authorised the first test to identify the emerging pathogen Candida auris, which can cause serious infections in hospitalised patients…
FDA takes actions to restrict kids' access to e-cigs biospectrumasia
April 26, 2018
In a statement from FDA Commissioner Scott Gottlieb, M.D., a new announcement has been made on recent enforcement actions aimed at curtailing access to e-cigarettes by young people.
Otsuka's Jynarque garners FDA approval for autosomal dominant polycystic kidney disease firstwordpharma
April 26, 2018
Otsuka Pharmaceutical announced that U.S. Food and Drug Administration approves Jynarque (tolvaptan) as the first drug treatment plan in the United States
FDA approves expanded use for GSK’s COPD triple therapy pharmaphorum
April 26, 2018
The FDA has approved an expanded label for GlaxoSmithKline’s new Trelegy Ellipta inhaler, allowing it to be used in a broader population of patients with chronic obstructive pulmonary disease (COPD).
FDA rejects Pfizer’s Herceptin biosimilar pharmatimes
April 25, 2018
US regulators have issued a complete response letter regarding Pfizer’s filing for a biosimilar version of Roche's blockbuster cancer drug Herceptin.
FDA advisors back Lilly/Incyte’s rheumatoid arthritis drug pharmatimes
April 25, 2018
US regulatory advisors are backing approval of the lower dose form of Eli Lilly and Incyte’s once-daily JAK inhibitor baricitinib as treatment for rheumatoid arthritis (RA).
FDA rejects Pfizer Herceptin biosimilar, wants technical info pharmaphorum
April 25, 2018
A Pfizer-produced biosimilar of Roche’s blockbuster breast cancer drug, Herceptin, has been rejected by US regulators.
Abeona Announces FDA Grants RMAT Designation to ABO-102 Gene Therapy in MPS IIIA biospace
April 25, 2018
Abeona Therapeutics Inc. announced today that the US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to ABO-102
Quotient Limited Announces FDA Approval of Seven Blood Bank Reagents, Including Two Market Firsts biospace
April 25, 2018
Quotient Limited today announced the recent FDA approval for U.S. commercialization of seven new blood bank reagents including two market firsts.

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