Regulation

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.

Concert receives FDA breakthrough status for CTP-543 in alopecia areata

Concert Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for the Company’s oral Janus kinase inhibitor, CTP-543, for the treatment of adult patients with moderate-to-severe alopecia areata.

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.

EMA grants accelerated assessment for trastuzumab deruxtecan in metastatic breast cancer

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for trastuzumab deruxtecan, a HER2 directed antibody drug conjugate (ADC), for the treatment of adults with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens.

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.