Merck is recalling some 22,000 vials of 500 mg Cubicin for intravenous injection following a complaint that a piece of glass was found in one of the vials post reconstitution.
The U.S. Food and Drug Administration approved GlaxoSmithKline’s new checkpoint inhibitor, Jemperli (dostarlimab), for patients with recurrent or advanced endometrial cancer.
Germany’s Boehringer Ingelheim partnered with Denmark’s Zealand Pharma A/S to study the GLP-1/glucagon dual agonist BI 456906 in two Phase II trials as a potential treatment for adults who are overweight or obese and for adults with non-alcoholic steatohepatitis (NASH).
The U.S. Food and Drug Administration approved a shorter two-hour infusion time for Roche Group member Genentech’s Ocrevus (ocrelizumab), dosed twice-yearly for those living with relapsing or primary progressive multiple sclerosis (MS) who have not experienced any prior serious infusion reactions.
Roche said two-thirds of spinal muscular atrophy (SMA) patients taking the Swiss drugmaker’s newly approved medicine Evrysdi have previously received rival treatments Zolgensma from Novartis or Biogen’s Spinraza.
The U.S. Food and Drug Administration granted accelerated approval for NS Pharma’s Viltepso (viltolarsen) injection for patients with Duchenne muscular dystrophy who are amenable to exon 53 skipping therapy.
Gilead Sciences Inc is developing easier-to-administer versions of the company’s antiviral treatment remdesivir for COVID-19 that could be used outside of hospitals.
Horizon Therapeutics Wins FDA Approval for First Thyroid Eye Disease TreatmentApprovals, Autoimmune Disorders, FDA, FDA/Regulatory, Graves' Disease, Infusions, Monoclonal Antibodies, New Drug Application (NDA), Orphan Drug Designation, Priority Review, Proptosis (Eye Bulging), Rare Diseases, Thyroid Eye Disease (TED), Thyroid Hormones
Ireland’s Horizon Therapeutics became the first to win regulatory approval in the United States for the treatment of Thyroid Eye Disease (TED), a progressive autoimmune disorder that can threaten the vision of those afflicted.
An experimental drug could offer hope for restoring damaged brain cells in Parkinson’s patients, scientists said on Wednesday, although they cautioned that a clinical trial was not able to prove the treatment slowed or halted the neurodegenerative disease.