Approvals

Shire’s haemophilia A drug Adynovi secures approval in Europe

The European Commission (EC) has granted marketing authorization for Shire’s Adynovi [Antihemophilic Factor (Recombinant), PEGylated], an extended half-life recombinant factor VIII (rFVIII) treatment, for on-demand and prophylactic use in patients 12 years and older living with hemophilia A.

FDA approves Lynparza in germline BRCA-mutated metastatic breast cancer

AstraZeneca and Merck have secured approval from the US Food and Drug Administration (FDA) for Lynparza (olaparib), for use in patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been earlier treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting.

FDA panel votes against approval of Lipocine’s testosterone replacement therapy

The US Food and Drug Administration's (FDA) Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) has decided not to recommend the approval of Lipocine's TLANDO.

AstraZeneca’s Fasenra gets approval in Europe for severe eosinophilic asthma

AstraZeneca has secured approval from the European Commission (EC) for Fasenra (benralizumab) as an add-on maintenance treatment for patients with severe eosinophilic asthma.

Lipocine Announces Outcome of FDA Advisory Committee Meeting for TLANDO, Testosterone Replacement Therapy in Adult Males with Hypogonadism

Lipocine Inc., a specialty pharmaceutical company, announced that the Bone, Reproductive and Urologic Drugs Advisory Committee ("BRUDAC") of the U.S. Food and Drug Administration ("FDA") voted six in favor and thirteen against the benefit/risk profile of TLANDO, the Company's oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.

FDA expands use of Amgen’s XGEVA drug

Amgen has secured approval from the US Food and Drug Administration (FDA) for its supplemental biologics license application (sBLA) of XGEVA (denosumab) to expand the currently approved indication to prevent skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma.

Novartis’ Promacta gets FDA breakthrough designation for severe aplastic anemia

Novartis’ drug Promacta (eltrombopag) has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for first-line treatment of severe aplastic anemia (SAA).

Roche secures cancer drug approvals in Europe and US

Switzerland-based drug manufacturer Roche has secured approvals for two cancer drugs in Europe and the US.

Spark’s gene therapy Luxturna secures FDA approval for rare form of blindness

Spark Therapeutics’ gene therapy Luxturna (voretigene neparvovec) has been approved by the US Food and Drug Administration (FDA) for the treatment of children and adults having a rare inherited form of vision loss that could lead to blindness.