Regulation

Acceleron gets FDA orphan drug designation for sotatercept in pulmonary arterial hypertension

Acceleron Pharma, a leading biopharmaceutical company in the discovery and development of TGF-beta superfamily therapeutics to treat serious and rare diseases, today announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug designation to sotatercept for the treatment of patients with pulmonary arterial hypertension (PAH).

Horizon secures FDA priority review for teprotumumab for treatment of active thyroid eye disease

Horizon Therapeutics plc (Nasdaq: HZNP) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for teprotumumab, an investigational medicine for the treatment of active thyroid eye disease (TED), and granted it Priority Review designation.

Boehringer Ingelheim’s Ofev secures FDA approval for SSc-ILD

Boehringer Ingelheim Pharmaceuticals has secured approval for Ofev (nintedanib) capsules from the US Food and Drug Administration (FDA) for the treatment of interstitial lung disease associated with systemic sclerosis or scleroderma (SSc-ILD).

SunGen Pharma receives seventh ANDA approval from US FDA

SunGen Pharma, a privately held specialty pharmaceutical company which develops, contract manufactures, and sells pharmaceutical finished products, today announced it has received its seventh ANDA approval from the US Food and Drug Administration (FDA).

Endo announces approval of first generic Orfadin in US

Endo International announced that Novitium Pharma, a partner of its subsidiary Endo Ventures, received approval from the US Food and Drug Administration for a room temperature stable, AB-rated, generic equivalent of Swedish Orphan Biovitrum's Orfadin (nitisinone capsules).

Allergan receives FDA approval of Juvéderm VOLUMA XC` for mid-face injection via cannula

Allergan has received U.S. Food and Drug Administration (FDA) approval for the use of Juvéderm VOLUMA XC, a hyaluronic acid gel dermal filler, with a TSK STERiGLIDE cannula for cheek augmentation to correct age-related volume deficit in the mid-face in adults over 21.

SpringWorks Therapeutics gets breakthrough therapy designation for nirogacestat to treat desmoid tumours

SpringWorks Therapeutics, Inc. a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for nirogacestat, an oral, selective, small molecule, gamma-secretase inhibitor, for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis.

Roche gets EC nod for Tecentriq plus Abraxane to treat metastatic TNBC

Roche has secured approval from the European Commission (EC) for its Tecentriq (atezolizumab) in combination with Abraxane to treat people with PD-L1-positive and metastatic triple-negative breast cancer (TNBC).

Emalex Biosciences receives FDA fast track designation for ecopipam for Tourette Syndrome

Emalex Biosciences, Inc. (Emalex), a biopharmaceutical company developing innovative therapies for patients with neurological and psychiatric conditions, announced today that it has received Fast Track designation for its investigational product, ecopipam, from the U.S. Food and Drug Administration (FDA) for the treatment of patients with Tourette Syndrome (TS).