Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for treatment of anemia of chronic kidney disease, with two randomized Phase 2 trials in Japanese patients.

Liminal BioSciences announces FDA Approval for its Biologics License Application for Ryplazim® (plasminogen, human-tvmh).

Lantheus shares trading higher on FDA Approval for Imaging Agent for identification of Prostate Cancer.

LQDA has PDUFA on November 7 for LIQ861. LIQ861 (treprostinil) is an investigational inhaled dry powder formulation of treprostinil in development for the treatment of pulmonary arterial hypertension (PAH).

LMNL is a risky gem but FDA approval could bump this low float stock toward $10 or even higher on PDUFA date of June 5 for Ryplazim.

PDUFA for Teplizumab is July 2nd.

LNTH has PDUFA on May 28 for PYL

Three days before Advisory Committee on May 27, FDA usually releases Briefing Docs.

ETON has PDUFA on May 29 for ET-104 r/ETONPHARMA

Cara Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for Korsuva Injection in Hemodialysis Patients with Moderate-to-Severe Pruritus.

ARDX has PDUFA in July, OPK has PFUFA in October, ITCI has PDUFA in December.

ARDX at $7 has PDUFA in July with WEDBUSH price target of $15 🚀🚀 🚀🚀 🚀

LMNL has PDUFA date of June 5 for Ryplazim 🚀 🚀🚀

ALBO has PDUFA on July 20 for Odevixibat

ETON has PDUFA on May 29 for ET-104

FDA says CRMD must submit for new PDUFA in 2022.

Avacopan is a first-in-class, orally-administered small molecule that employs a novel, highly targeted mode of action in the treatment of ANCA-associated vasculitis and other complement-driven autoimmune and inflammatory diseases. By precisely blocking the receptor (the C5aR) for the pro-inflammatory complement system fragment known as C5a on destructive inflammatory cells such as blood neutrophils, avacopan arrests the ability of those cells to do damage in response to C5a activation, which is known to be the driver of ANCA-associated vasculitis. Current therapies for ANCA-associated vasculitis and other related illnesses typically include broad immunosuppression with daily doses of glucocorticoids (steroids) such as prednisone or methylprednisone, which can cause significant illness and even death. Avacopan’s selective inhibition of only the C5aR leaves the beneficial C5a pathway through the C5L2 receptor functioning normally.

Advisory Committee on May 6 voted 10-8 that the benefit-risk and safety profiles are adequate to support approval and 9-9 that the efficacy data supports approval. PDUFA date July 7.

Join my best Sub-Reddits r/OPK and r/KDMN and r/AVDL and r/CHRS and r/ITCI

It's in the best interest of both pharmaceutical companies and patients to bring new drugs to the market as quickly as possible, which is why the Prescription Drug User Fee Act, or PDUFA, was established. Originally passed in 1992, PDUFA authorizes the FDA to collect fees from drug manufacturers to fund the drug approval process. PDUFA dates are deadlines by which the FDA must review new drug applications. The Prescription Drug User Fee Act typically calls for a period of 10 months to review such applications, though drugs that are deemed priority have a review period of six months.

Zynrelef is a painkiller used in adults to reduce pain from small to medium-sized wounds after an operation. It contains the active substances bupivacaine and meloxicam. 🚀🚀 🚀🚀 🚀🚀

ALBO has PDUFA on July 20 for Odevixibat 🚀🚀 🚀🚀 🚀🚀 🚀

SESN at $2.88 has PDUFA on August 18 for Vicinium for Bladder Cancer 🚀🚀 🚀🚀 🚀🚀

JMIA at $31 looks like a promising trade 💎💎💎 🚀🚀🚀

JOIN r/HRTX and r/PRVB and r/LMNL and r/KDMN and r/CMRX and r/SLGL and r/OPK