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, 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 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 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, 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 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, 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).
AstraZeneca’s Fasenra (benralizumab) has been granted orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of eosinophilic oesophagitis (EoE).
The U.S. Food and Drug Administration today approved Nourianz (istradefylline) tablets as an add-on treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing "off" episodes.
Johnson & Johnson (NYSE: JNJ) and its Janssen Pharmaceutical Companies today announced they will appeal the $572 million civil judgment entered in Cleveland County District Court in the State of Oklahoma’s lawsuit against opioid manufacturers.
Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.