Ono Pharmaceutical Co., Ltd. announced that the FDA has accepted for filing the New Drug Application (NDA) under the accelerated approval pathway for tirabrutinib, a highly selective irreversible,… read more.
Pfizer Inc. announced positive results from Cohort 3, a separate randomized cohort of the pivotal BREAKWATER trial, evaluating Braftovi (encorafenib) in combination with cetuximab (Erbitux) and FOLFIRI (fluorouracil,… read more.
Zevra Therapeutics announced the presentation of four posters highlighting positive new data on Miplyffa (arimoclomol) for the treatment of Niemann-Pick Disease Type C (NPC) at the 22nd Annual… read more.
Alfresa Pharma released Neffy 1 mg and Neffy 2 mg (adrenaline, epinephrine), which are nasal sprays used as emergency supportive therapy to suppress anaphylaxis, to the Japanese market…. read more.
GSK announced that China’s National Medical Products Administration (NMPA) has approved Nucala (mepolizumab) as add-on maintenance treatment of adult patients with inadequately controlled COPD characterised by raised blood… read more.
Shionogi & Co., Ltd. announces that its group company, Torii Pharmaceutical Co., Ltd., has issued a press release about the launch in Japan of Ycanth (cantharidin) topical solution… read more.
ARS Pharmaceuticals, Inc. announced that five poster presentations, one healthcare professional (HCP) case report, plus two late breakers from partners at ALK-Abelló A/S (ALK) centered on neffy, will… read more.
The FDA has accepted for priority review the supplemental biologic license application (sBLA) for Tzield (teplizumab-mzwv) to expand the current age indication from eight years and above, to… read more.
NICE (UK): Avelumab plus axitinib can be used as an option for untreated advanced renal cell carcinoma (RCC) in adults, only if: i) they have a favourable-risk status,… read more.
Health Canada has issued a Notice of Compliance with conditions (NOC/c) for Voxzogo (vosoritide for injection) a modified recombinant human C-type natriuretic peptide 39 (CNP-39) for the treatment… read more.
The European Medicines Agency (EMA) has given its approval for six new medicines, with another nine products receiving extensions for their therapeutic indications. The decisions came as the… read more.
Gilead Sciences Inc. announced Trodelvy (sacituzumab govitecan-hziy) has now been added to the NCCN Guidelines as a category 1 preferred first-line treatment option for people with metastatic triple-negative… read more.
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