Delivers up-to-date industry news on topics like drug approvals, product recalls, company expansions and acquisitions, market trends for all OSD forms, as well as excipients, packaging and supply chain issues. Monitors market trends in specific drug categories as well as in supplements/nutraceuticals. Provides updates on clinical trials. Includes alerts about new or upcoming regulatory issues.
Compared to the standard of care, the therapy led to a progression-free survival of 18 months vs. 8.3 months.
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Between exposure and day 10, the drug reduced the risk of symptomatic COVID by 67%.
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The agency is extending the PDUFA date for the company’s camizestrant combination, citing a need to review additional data to support the NDA.
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The LRRK2 inhibitor failed to slow the progression of idiopathic Parkinson’s disease and didn't meet any of the phase 2 trial’s secondary endpoints.
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The company offers a natural colorant portfolio, produced via fermentation of baker's yeast.
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Acting directors of CDER and CBER are both leaving their roles.
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The new identity is not the result of an acquisition or merger; it is a strategic step that consolidates the company's operations under one brand.
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Kissei Pharmaceutical has issued a safety alert regarding Tavneos.
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Beqalzi is the first approved BCL2 inhibitor to treat relapsed or refractory mantle cell lymphoma.
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Aardvark will be unblinding data from its phase 3 trials to find a way to continue the ARD-101 program.
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Baxfendy reduces systolic blood pressure by inhibiting the production of the hormone aldosterone, lowering the risk for heart and kidney problems.
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The treatment will be available to newly-diagnosed patients who are ineligible to receive intensive induction chemotherapy or aged 75 years or older.
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According to AP News, Makary resigned under pressure from HHS Secretary Robert Kennedy Jr. and the decision was backed by the White House.
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When approved, the incidence rate for SPMs was 1.7%, but a phase 3 trial this year found the risk of SPMs to be 5.7%.
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The acquisition will give Angelini Pharma the oral drug Firdapse, the only FDA approved treatment for LEMS.
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