Pharmacists Play a Role in Responding to Drug Shortages
December 3rd 2018In a satellite symposium at the 2018 American Society of Health-Systems Pharmacists (ASHP) Midyear Clinical Meeting in Anaheim, CA, the increasing rate of drug shortages was discussed, along with best practices pharmacists can use to mitigate the ongoing issue.
Read More
FDA Approves Adcetris with Chemo for First-Line Peripheral T-Cell Lymphoma Treatment
November 17th 2018The FDA has expanded the approved use of Seattle Genetics’ Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma.
Read More
First-line Treatment for PTCL Granted FDA Approval Under New Review Pilot
November 17th 2018The FDA has expanded the approved use of Seattle Genetics’ Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL).
Read More
FDA Approves Pegfilgrastim Biosimilar for Patients Receiving Myelosuppressive Chemotherapy
November 3rd 2018Officials with the FDA have approved Coherus BioSciences’ Udenyca (pegfilgrastim-cbqv) for patients with cancer receiving myelosuppressive chemotherapy. The drug is a biosimilar to Amgen’s Neulasta (pegfilgrastim).
Read More
FDA Grants Approval to Biosimilar for Patients Receiving Myelosuppressive Chemotherapy
November 3rd 2018Officials with the FDA have approved Coherus BioSciences’ Udenyca™ (pegfilgrastim-cbqv) for patients with cancer receiving myelosuppressive chemotherapy. The drug is a biosimilar to Amgen’s Neulasta (pegfilgrastim).
Read More
Generic Clobazam Tablets Granted FDA Approval
October 24th 2018Breckenridge Pharmaceutical's Clobazam Tablets, CIV, generic for Onfi® Tablets (Lundbeck), has been granted FDA approval for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients aged 2 years and older.
Read More
FDA Approves Dupilumab as Additional Maintenance Therapy in Certain Children with Asthma
October 22nd 2018The FDA has approved dupilumab (Dupixent®, Regeneron and Sanofi) as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma.
Read More
Positive Topline Results Shown for Dupilumab in Phase 3 Trials in Patients with CRSwNP
October 17th 2018A pair of pivotal Phase 3 placebo-controlled trials that evaluated dupilumab (Dupixent, Sanofi and Regeneron) for adults with inadequately-controlled chronic rhinosinusitis with nasal polyps met all primary and secondary endpoints.
Read More
FDA Approves Second Drug Treatment for Polyneuropathy
October 6th 2018The FDA has approved Akcea Therapeutics' inotersen (Tegsedi), an antisense oligonucleotide that inhibits the production of the transthyretin protein (amyloid), for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
Read More
FDA OKs Treatment for Community-Acquired Bacterial Pneumonia and Skin Infections
October 4th 2018FDA officials have approved omadacycline (Nuzyra, Paratek), a modernized tetracycline, to treat adults with acute skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).
Read More