BioMarin Pharmaceutical Inc. announced that the company submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for vosoritide, an investigational, once daily injection analog of… read more.
CymaBay Therapeutics announced that the FDA lifted clinical holds on seladelpar for all three Investigational New Drug (IND) Applications in Nonalcoholic Steatohepatitis (NASH), Primary Biliary Cholangitis (PBC) and… read more.
G1 Therapeutics, Inc. a clinical-stage oncology company, announced a license agreement for lerociclib to EQRx, a biopharmaceutical company focused on making innovative medicines at dramatically lower prices for… read more.
AstraZeneca’s Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) has been approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). The approval by the FDA… read more.
Acadia Pharmaceuticals Inc. announced top-line results from its 298 patient Phase III CLARITY study which combined two identical, double-blind, placebo-controlled studies evaluating the efficacy, safety and tolerability of… read more.
Genentech, a member of the Roche Group announced detailed results from the Phase III Archway study evaluating its investigational Port Delivery System with ranibizumab (PDS) for the treatment… read more.
Acadia Pharmaceuticals Inc.announced that the FDA has accepted for filing its supplemental New Drug Application (sNDA) for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with… read more.
Jazz Pharmaceuticals plc announced that the FDA approved Xywav (calcium, magnesium, potassium, and sodium oxybate) oral solution on July 21, 2020 for the treatment of cataplexy or excessive… read more.
Aurinia Pharmaceuticals Inc., a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple indications, announced that the FDA has accepted the filing of its New Drug Application… read more.
BioXcel Therapeutics announced that BXCL 501 (sublingual dexmedetomidine), met the primary and secondary endpoints of SERENITY I and SERENITY II, demonstrating a robust treatment effect in the trials… read more.
Interim results from the ongoing Phase I/II COV001 trial, led by Oxford University, showed AZD 1222 vaccine, from AstraZeneca, was tolerated and generated robust immune responses against the… read more.
Synairgen announced positive results from its clinical trial of SNG001, its wholly-owned inhaled formulation of interferon beta, in hospitalised COVID-19 patients. The double-blind placebo-controlled trial recruited 101 patients… read more.
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