Summary: EPSOLAY (benzoyl peroxide, cream, 5%) utilizes Sol-Gel’s proprietary microencapsulation technology for the treatment of inflammatory lesions of rosacea and is patent…
Approval
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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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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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437 RC meetingCIBRC - Indian Pesticide ApprovalsRC Meeting updates
INDIA CIBRC UPDATES – MINUTES OF THE 437th REGISTRATION COMMITTEE (RC) MEETING HELD ON 16.03.2022.
by adminby adminMINUTES OF THE 437th REGISTRATION COMMITTEE (RC) MEETING HELD ON 16.03.2022. The 437th meeting of the Registration Committee (RC) was held under…
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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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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…
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Summary : Several FDA-approved drugs – including for type 2 diabetes, hepatitis C and HIV – significantly reduce the ability of the…
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RegulatoryU.S FDA
GC Pharma Receives Complete Response Letter From the U.S. FDA For ‘ALYGLO’
by adminby adminSummary : GC Pharma (KRX:006280) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug…
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Summary : One of Eli Lilly’s diabetes drugs just scored another win with the U.S. Food and Drug Administration to expand its…
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AstraZenecaCovid DrugsRegulatoryU.S FDA
FDA Adjusts EUA Dosing On Evusheld To Fight Omicron
by adminby adminSummary: The U.S. Food and Drug Administration (FDA) has revised its emergency use authorization (EUA) for AstraZeneca’s Evusheld to a higher dose…