GSK announces EMA accepted for review MAA for depemokimab

EMA Accepts GSK's Filing for Depemokimab in Two Respiratory Diseases
GSK plc GSK recently announced that EMA has accepted the regulatory filing seeking approval for its IL-5 inhibitor depemokimab in two respiratory indications – asthma with type II inflammation and chronic rhinosinusitis with nasal polyps (CRSwNP).
GSK announces EMA accepted for review the MAA for depemokimab
GSK (GSK) announced that the European Medicines Agency, EMA, has accepted for review the Marketing Authorisation Application, MAA, for the use of depemokimab in two indications. The submitted indicati
GSK announces new drug applications accepted for review in China, Japan
GSK (GSK) announced that new drug applications have been accepted for review by the China National Medical Products Administration and
EMA accepts for review GSK’s MAA for depemokimab for use in asthma with type 2 inflammation and CRSwNP
EMA accepts for review GSK’s MAA for depemokimab for use in asthma with type 2 inflammation and CRSwNP: London, UK Wednesday, January 29, 2025, 09:00 Hrs [IST] GSK plc announced
GSK's depemokimab under review in China and Japan for asthma, CRSwNP
GSK plc (LSE/NYSE: GSK), a prominent pharmaceutical company with a market capitalization of $71.31 billion and an impressive gross profit margin of 72.39%, has announced that its new drug applications for depemokimab have been accepted for review by the China National Medical (TASE:PMCN) Products Administration and submitted to the Japanese Ministry of Health,
GSK says asthma and nasal polyps therapy under EU review
GSK (NYSE:GSK) announced Tuesday that the EU drug regulator has agreed to review depemokimab, an experimental monoclonal antibody targeting a class of cell signaling molecules called interleukin-5, for the treatment of asthma and nasal polyps.
GSK falls Tuesday, underperforms market
GSK PLC closed 23.91% below its 52-week high of £18.24, which the company reached on May 16th.
GSK and Oxford researchers to create cancer vaccine to stop disease developing
GSK will invest up to £50 million in the new project, which could inform future development of cancer vaccines.
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Stopwatch starts on reviews of GSK's long-acting asthma drug
Depemokimab is a follow-up to GSK's Nucala (mepolizumab), a once-monthly IL-5 inhibitor approved for severe asthma, CRSwNP, ...
GSK rises Monday, outperforms market
GSK PLC GSK shares advanced 3.35% to £14.02 Monday, on what proved to be an all-around great trading session for the stock ...
GSK Pharma put volume heavy and directionally bearish
Bearish flow noted in GSK (GSK) Pharma with 1,694 puts trading, or 4x expected. Most active are 2/7 weekly 34 puts and Jan-27 28 puts, with total volume in those strikes near 1,600 contracts. The ...
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EMA accepts for review regulatory application of GSK’s Shingrix new prefilled syringe presentation for prevention of shingles
EMA accepts for review regulatory application of GSK’s Shingrix new prefilled syringe presentation for prevention of shingles: London, UK Wednesday, January 29, 2025, 13:00 Hrs ...
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Earnings Preview: GSK (GSK) Q4 Earnings Expected to Decline
GSK (GSK) is expected to deliver a year-over-year decline in earnings on lower revenues when it reports results for the quarter ended December 2024. This widely-known consensus outlook gives a good ...