Regulation - Approvals

FDA approves Roche’s Tecentriq plus Cotellic and Zelboraf for people with advanced melanoma

Roche announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab) plus Cotellic® (cobimetinib) and Zelboraf® (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma patients. The safety profile observed in the Tecentriq combination was consistent with the known safety profiles of the individual medicines.

Novartis gets EC nod for Cosentyx drug in paediatric psoriasis

Novartis has secured approval from the European Commission (EC) for its Cosentyx (secukinumab) to treat moderate-to-severe plaque psoriasis in children and adolescents aged between six and 18 years

Takeda gets FDA breakthrough therapy status for pevonedistat to treat higher-risk HR-MDS

Takeda Pharmaceutical has secured a breakthrough therapy designation from the US Food and Drug Administration (FDA) for its investigational drug pevonedistat to treat patients with higher-risk myelodysplastic syndromes (HR-MDS).

Jazz Pharmaceuticals gets US FDA approval of Xywav for cataplexy associated with narcolepsy

Jazz Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution on July 21, 2020 for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.

EC approves new indication for Boehringer’s nintedanib in pulmonary fibrosis

Boehringer Ingelheim has secured approval for a new indication of nintedanib to treat adults with other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype beyond idiopathic pulmonary fibrosis (IPF).

Janssen’s Tremfya gets FDA approval for active psoriatic arthritis

Janssen Pharmaceutical has secured approval from the US Food and Drug Administration (FDA) for Tremfya (guselkumab) for the treatment of active psoriatic arthritis (PsA) in adults.

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.