Summary : First and only nitric oxide generator and delivery system indicated for the treatment of termand near-term neonates with hypoxic respiratory…
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Tag:
Approval
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CompaniesGlobal MarketMerck & CoRegulatoryU.S FDA
Merck Scores FDA Approval for Vaxneuvance ( Pneumococcal 15-valent conjugate vaccine) for Ages 6 Weeks through 17 Years
by adminby adminSummary : The FDA today approved the pneumococcal 15-valent conjugate vaccine for the prevention of invasive pneumococcal disease in infants and children.…
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AbbVieCompaniesRegulatoryU.S FDA
AbbVie’s Skyrizi (risakizumab-rzaa) Becomes First FDA-Approved IL-23 Inhibitor for Crohn’s Disease
by adminby adminSummary : Third approved indication for SKYRIZI (risankizumab-rzaa) is supported by safety and efficacy data from two induction and one maintenance clinical…
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439 RC meetingCIBRC - Indian Pesticide ApprovalsRC Meeting updates
INDIAN PESTICIDE APPROVALS UPDATES – MINUTES OF THE 439TH REGISTRATION COMMITTEE (RC) MEETING HELD ON 22.04.2022
by adminby adminINDIAN PESTICIDE APPROVALS UPDATES – MINUTES OF THE 439TH REGISTRATION COMMITTEE (RC) MEETING HELD ON 22.04.2022. The 439th meeting of the Registration…
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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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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…