Category: Drug Approvals

September 11, 2021 0

AK-OTOF to treat otoferlin gene-mediated hearing loss in EU

By Team FM

The European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) issued a positive opinion on the application for orphan drug designation for AK-OTOF, a gene therapy intended for the treatment of otoferlin gene-mediated hearing loss, Akouos, Inc announced.

May 8, 2021 0

Viloxazine for treatment of ADHD

By FM

Supernus Pharmaceuticals announced that the US FDA approved viloxazine extended-release capsules (Qelbree) for the treatment of attention-deficit hyperactivity disorder (ADHD) in paediatric patients 6 to 17 years of age.

June 10, 2020 0

Ozanimod to treat adult patients with active MS

By FM

Bristol Myers Squibb announced that the European Commission (EC) has approved ozanimod (Zeposia) for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease.

June 10, 2020 0

Atezolizumab as first-line monotherapy for mNSCLC

By FM

Atezolizumab (Tecentriq) has been granted approval by the US FDA as a first-line treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression (PD-L1 stained = 50% of tumour cells [TC = 50%] or PD-L1 stained tumour-infiltrating [IC] covering = 10% of the tumour area [IC = 10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumour aberrations.

June 10, 2020 0

Pomalidomide for Kaposi sarcoma

By FM

Pomalidomide (Pomalyst) has been granted approval by the US FDA for patients with AIDS-related Kaposi sarcoma whose disease has become resistant to highly active antiretroviral therapy (HAART), or in patients with Kaposi sarcoma who are HIV-negative.

June 10, 2020 0

Brentuximab ADC to treat sALCL in China

By FM

Takeda China announced that brentuximab vedotin (Adcetris) has been officially approved by China’s National Medical Products Administration (NMPA) for use in adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL) or CD30-positive Hodgkin lymphoma.

June 10, 2020 0

Glycopyrronium/formoterol aerosphere for COPD in China

By FM

AstraZeneca announced that its glycopyrronium/formoterol fumarate (Bevespi Aerosphere) has been approved in China as a maintenance treatment to relieve symptoms in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.