AstraZeneca announced high-level results from Farxiga’s (dapagliflozin) Phase III DAPA-CKD trial showed a statistically significant and clinically meaningful effect on its primary endpoint of a composite of worsening… read more.
Pfizer Inc. and BioNTech SE announced the start of a global (except for China) Phase II/III safety and efficacy clinical study to evaluate a single nucleoside-modified messenger RNA… read more.
AbbVie announced Rinvoq (upadacitinib 15 mg and 30 mg, once daily) plus topical corticosteroids (TCS) met the co-primary endpoints and all secondary endpoints in AD Up, the third… read more.
Orion’s phase III REFALS trial evaluating the efficacy of oral Simdax (levosimendan) in treatment of amyotrophic lateral sclerosis (ALS) patients did not reach its pre-specified endpoints. Orion has… read more.
Health Canada has approved, with conditions, remdesivir (Velkury) from Gilead Sciences to treat COVID-19 patients. Remdesivir is used to treat those with pneumonia who need extra oxygen to… read more.
MC2 Therapeutics, announced that the FDA has approved Wynzora Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) for once-daily topical treatment of plaque psoriasis in adults 18 years of… read more.
scPharmaceuticals Inc. announced that the FDA has accepted for review the company’s New Drug Application (NDA) resubmission for Furoscix. scPharmaceuticals is developing Furoscix a proprietary, subcutaneously delivered furosemide… read more.
Imfinzi (durvalumab) has been recommended for marketing authorisation in the European Union (EU) for the 1st-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) in combination… read more.
Moderna announced a modification to its contract with the Biomedical Advanced Research and Development Authority (BARDA) for an additional commitment of up to $472 million to support late… read more.
The Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Ayvakyt (avapritinib), from Blueprint… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Calquence (acalabrutinib), from AstraZeneca,… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Zynrelef (bupivacaine and meloxicam),… read more.
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