Summary : The Food and Drug Administration (FDA) has approved a novel first-in-class drug to treat type 2 diabetes. The drug is…
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FDA
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RegulatoryU.S FDA
Phathom Pharmaceuticals Announces FDA Approval of VOQUEZNA™ TRIPLE PAK™ (Vonoprazan, Amoxicillin, Clarithromycin) and VOQUEZNA™ DUAL PAK™ (Vonoprazan, Amoxicillin) for the Treatment of H. pylori Infection in Adults
by adminby adminSummary : The FDA approved two vonoprazan-based regimens, one with amoxicillin and clarithromycin (Voquezna Triple Pak) and one with amoxicillin (Voquezna Dual…
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Summary : HYFTOR™ is the first topical treatment approved by the FDA for facial angiofibroma in individuals with tuberous sclerosis complex (TSC) 6…
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Global MarketRegulatoryU.S FDA
Sol-Gel Technologies and Galderma’s EPSOLAY® Scores US FDA Approval
by adminby adminSummary: EPSOLAY (benzoyl peroxide, cream, 5%) utilizes Sol-Gel’s proprietary microencapsulation technology for the treatment of inflammatory lesions of rosacea and is patent…
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RegulatoryU.S FDA
Alymsys® (Bevacizumab-maly), a Biosimilar of Bevacizumab developed by mAbxience, has been Approved by the FDA.
by adminby adminSummary : ALYMSYS® was developed by mAbxience, a global biotech company with over a decade of experience in the development, manufacture, and commercialization…
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Amgen Inc.Merger / Acquisition
Amgen has bought Five Prime Therapeutics for $1.9 Billion
by adminby adminSummary : Five Prime’s lead asset, Bemarituzumab, is a first-in-class, Phase 3 ready anti-FGFR2b antibody with positive data from a randomized, placebo-controlled…
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RegulatoryU.S FDA
First Generic of Symbicort (Budesonide and Formoterol Fumarate Dihydrate) Receives FDA Approval
by adminby adminSummary : The U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol to…
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RegulatoryU.S FDA
FDA approves first generic of Symbicort to treat asthma and COPD
by adminby adminSummary : Today, the U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol…
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Summary : Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced an initial donation of essential medicines to Ukraine. Roche vehemently condemns the…
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RegulatoryU.S FDA
Expert: Newly Appointed FDA Commissioner Robert Califf Is Perfectly Positioned to Advance the FDA’s Accelerated Approval Pathway
by adminby adminSummary : Peter Pitts, a former FDA associate commissioner and president of the Center for Medicine in the Public Interest, discusses the…