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Jazz Pharmaceuticals Announces FDA Acceptance of NDA for Solriamfetol (JZP-110) for Excessive Sleepi biospace
March 05, 2018
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) announced today that the U.S. Food and Drug Administration (FDA) has accepted a standard review
FDA warns of fraudulent and unapproved flu products biospace
March 05, 2018
As part of FDA's ongoing efforts to protect consumers from health fraud, the agency is reminding consumers to be wary of unapproved products claiming to prevent, treat or cure influenza, or flu.
FDA Issues New Draft Guidance for Alzheimer’s Trials that Could Open Up Approvals biospace
March 05, 2018
Merck & Company’s recent failure of verubecestat (MK-8931) in Alzheimer’s underlines just how difficult it has been for researchers to come up with meaningful treatments for the disease.
FDA approves label update of Cosentyx to include scalp psoriasis europeanpharmaceuticalreview
March 02, 2018
The FDA has approved a label update for Cosentyx, the first interleukin-17A inhibitor approved to treat moderate-to-severe plaque psoriasis…
Natco Pharma seeks US FDA approval for hepatitis drug expressbpd
March 02, 2018
The company believes that “they are the first to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity upon receiving final FDA approval.”
Zydus Cadila gets US FDA nod for sedative injection expressbpd
March 01, 2018
The injection will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad
MabSpace granted FDA Approval for MSB2311 IND biospectrumasia
March 01, 2018
MabSpace Biosciences Announces FDA Approval of IND for MSB2311, a Second Generation PD-L1 Antibody With pH Dependent Antigen Binding and Recycling Property
Lilly Receives Additional FDA Approval for Verzenio Americanpharmaceuticalreview
February 28, 2018
Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has approved Verzenio (abemaciclib) in combination with an aromatase inhibitor (AI) ...
Alma Lasers gets FDA clearance for its award winning Soprano ICE platform biospectrumasia
February 27, 2018
Alma Lasers Receives New FDA Clearance on its Award Winning Soprano ICE Platform, the Gold Standard in Laser Hair Removal, Signaling a New Era in Aesthetic Technology Advancement
Shionogi's thrombocytopenia drug granted 'priority review' by the US FDA biospectrumasia
February 27, 2018
The drug has already bagged the Japanese approval in September 2015 for the improvement of thrombocytopenia associated with chronic liver disease

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