Fierce Pharma

DECEMBER 27, 2023

Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. The California biopharma will now have to conduct an additional confirmatory trial to gain the coveted FDA nod.

FDA 318

FDA Biopharma 318

PM360

DECEMBER 14, 2023

With its new funding, the company is developing a roadmap to an overall goal of automating the entire document process across pharma, from preclinical trials all the way through FDA approval. The company’s enterprise software platform, Yseop Copilot, leverages pre-trained large language models (LLM) built for the biopharma industry.

Physicians 52

Physicians Pharma Medical Patients 52

MedCity News

DECEMBER 19, 2023

Chiesi Group’s Filsuvez is the second drug to win FDA approval for epidermolysis bullosa and the first for junctional EB, a more severe form of the rare skin disease. The birch tree bark-derived drug is from Chiesi’s $1.25 billion Amryt Pharma acquisition.

FDA 106

FDA Pharma Biopharma 106

MedCity News

DECEMBER 28, 2023

The FDA said promethazine hydrochloride, a generic drug used to manage allergies and motion sickness, should be administered by intramuscular injection. Intravenous injection can cause chemical irritation and tissue damage, an FDA alert states.

FDA 105

FDA Management Biopharma Pharma 105

MedCity News

DECEMBER 6, 2023

FDA approval of Novartis’s Fabhalta makes the drug the first approved oral therapy for rare blood disorder paroxysmal nocturnal hemoglobinuria. With clinical data showing superiority versus two infused AstraZeneca drugs, Novartis’s pill is well-positioned to take market share from those blockbuster products.

FDA 105

FDA Marketing Biopharma Pharma 105

MedCity News

DECEMBER 8, 2023

The first gene therapies for sickle cell disease are now approved: Casgevy from Vertex Pharmaceuticals Casgevy and Lyfgenia from Bluebird Bio. Despite the same-day approval, key differences give one of these therapies commercialization advantages over the other.

FDA 102

FDA Pharmaceutical Biopharma Pharma 102

MedCity News

DECEMBER 4, 2023

Eli Lilly’s Jaypirca is now approved for treating three types of blood cancers. While Jaypirca blocks a target already addressed by other cancer therapies, the Lilly molecule does it in a way that sets it apart from the rest of its drug class.

FDA 89

FDA Biopharma Pharma 89