Approvals

FDA grants orphan drug designation for Inflazome’s Inzomelid to treat cryopyrin-associated periodic syndromes

Inflazome, the pioneering inflammasome biotech company developing multiple drugs that stop harmful inflammation, today announces that it has been granted orphan drug designation by the US Food and Drug Administration (FDA) for Inzomelid in the treatment of Cryopyrin-Associated Periodic Syndrome (CAPS).

Pfizer, BioNTech get FDA fast track status for two coronavirus vaccine candidates

Pfizer and Biopharmaceutical New Technologies (BioNTech) have secured fast track designation from the US Food and Drug Administration (FDA) for two investigational mRNA-based vaccine candidates against SARS-CoV-2, the novel coronavirus responsible for the Covid-19 disease.

AstraZeneca, Merck secure EU nod for Lynparza to treat germline BRCA-mutated metastatic pancreatic cancer

AstraZeneca and Merck have secured approval from the European Union (EU) for the Lynparza as a maintenance treatment for adult patients with germline BRCA-mutated metastatic pancreatic cancer.

FDA grants orphan drug designation to Neurogene’s gene therapy for treatment of CLN5 Batten disease

Neurogene, a company founded with a mission to bring life-changing genetic medicines to patients and families affected by rare neurological diseases, today announced that the US Food and Drug Administration (FDA) granted Orphan Drug Designation to adeno-associated virus vector with engineered transgene encoding the human CLN5 gene for patients with CLN5, a form of Batten disease.

Gilead Sciences gets EC conditional approval for Veklury to treat Covid-19 disease

Gilead Sciences has secured conditional marketing authorisation from the European Commission for its Veklury (remdesivir) to treat SARS-CoV-2 infection, which is responsible for the Covid-19 disease.

ViiV Healthcare gets FDA nod for HIV drug Rukobia to treat adult patients

Specialist HIV company ViiV Healthcare has secured approval from the US Food and Drug Administration (FDA) for its Rukobia (fostemsavir) 600mg extended-release tablets to treat HIV in adult patients.

Janssen gets EC approval for Ebola vaccine regimen

Janssen Pharmaceutical, part of Johnson & Johnson, has secured marketing authorisation from the European Commission (EC) for its Ebola vaccine regimen to prevent Ebola virus disease.

Oncternal gets FDA orphan drug designations for cirmtuzumab to treat MCL and CLL

Oncternal Therapeutics, a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, announced that the United States Food and Drug Administration (FDA) has granted the company orphan drug designations of cirmtuzumab for treatment of mantle cell lymphoma (MCL) and for treatment of chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL).

Pfizer gets EC approval for Daurismo to treat newly diagnosed acute myeloid leukaemia

Pfizer has secured approval from the European Commission (EC) for its Daurismo (glasdegib) to treat certain adult patients with newly diagnosed acute myeloid leukaemia (AML).