The latest news from the global pharmaceutical industry. Below you will find news and information to keep you up-to-date with what is happening in your industry. Coverage includes regulatory approvals, recall announcements, mergers and acquisitions, personnel news and appointments, new facility and facility expansion updates, collaborations and agreements, and financial updates.
ANI has submitted a PAS to the Endocrinology Division at the FDA for re-commercialization of Purified Cortrophin Gel.
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Wednesday, March 25, 2020
Ampio is preparing an expanded access FDA protocol to study potential benefit of nebulized treatment with Ampion in COVID-19 induced ARDS.
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Wednesday, March 25, 2020
The FDA approved a supplemental application for Epclusa (sofosbuvir and velpatasvir) to treat hepatitis C virus in children ages 6 years and older.
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Samsung Bioepis announced the FDA has approved a 420 mg multi-dose vial of ONTRUZANT, a biosimilar referencing HERCEPTIN.
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At the direction of the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense, the Medical CBRN Defense ...
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Celsion announced the EMA COMP has recommended that GEN-1 be designated as an orphan medicinal product for the treatment of ovarian cancer.
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Biohaven announced verdiperstat received Fast Track designation from the FDA for the treatment of multiple system atrophy.
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Wednesday, March 18, 2020
Provention Bio announced positive top-line results from the Phase 1b portion of the PREVAIL study evaluating PRV-3279 in healthy volunteers.
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Wednesday, March 18, 2020
Diatherix Eurofins has developed a test for the SARS-CoV-2 virus, the cause of the COVID-19 respiratory infection, as part of its proprietary ...
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Pfizer and BioNTech announced the companies have agreed to a letter of intent regarding the co-development and distribution of a potential mRNA-based ...
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Catalent welcomed the announcement by Biohaven the FDA has approved its NURTEC™ ODT for acute migraine in adults.
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FDA, Thermo Fisher Scientific
Thermo Fisher Scientific announced the FDA issued an EUA for its diagnostic test that can be used immediately to detect nucleic acid from SARS-CoV-2, ...
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CureVac AG has confirmed internal efforts are focused on the development of a coronavirus vaccine.
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Agenus announced the FDA has granted Agenus Fast Track designation for investigation of balstilimab in combination with zalifrelimab for relapsed or ...
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I-Mab Biopharma is initiating the development of TJM2 (TJ003234) to treat cytokine storm in severe and critically ill patients caused by the ...
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