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Merck (MRK) Gets Priority Tag for Antiviral Drug Prevymis sNDA
Zacks via Yahoo Finance· 1 year agoMerck MRK announced that the FDA has accepted and granted priority review to a supplemental new drug...
Blueprint Medicines' (BPMC) Aykavit sNDA Gets FDA Priority Tag
Zacks via Yahoo Finance· 1 year agoBlueprint Medicines Corporation BPMC announced that the FDA has accepted its supplemental new drug...
Arcutis (ARQT) Files sNDA for Zoryve in Atopic Dermatitis, Stock Up
Zacks via Yahoo Finance· 8 months agoArcutis Biotherapeutics ARQT announced that it submitted a supplemental new drug application (sNDA)...
Vanda (VNDA) Falls on FDA's CRL to Hetlioz sNDA for Insomnia
Zacks via Yahoo Finance· 2 months agoShares of Vanda Pharmaceuticals Inc. VNDA were down 5.6% on Mar 6 after the company announced that...
Pacira (PCRX) Gets FDA Nod for Exparel's Label Expansion
Zacks via Yahoo Finance· 6 months agoPacira BioSciences, Inc. PCRX announced that the FDA has approved its supplemental new drug...
Bristol Myers (BMY) Gets FDA Nod for Data Addition to Camzyos
Zacks via Yahoo Finance· 11 months agoBristol Myers Squibb BMY announced that the FDA approved the supplemental new drug application...
Rhythm Pharmaceuticals Reports Q1 2024 Results: Revenue Growth Amidst Challenges
GuruFocus.com via Yahoo Finance· 6 hours agoRevenue: Reported Q1 2024 net revenue of $26.0 million from global sales of IMCIVREE, falling short of estimates of $26.90 million. Net Loss: Q1 2024 net loss widened to $141.37 million, significantly ...
Pacira's (PCRX) sNDA for Exparel Accepted for FDA Review
Zacks via Yahoo Finance· 1 year agoThe FDA accepts Pacira's (PCRX) sNDA filing, which seeks to expand the label of its pain drug...
Catalyst Pharma's (CPRX) sNDA for Firdapse Approved by the FDA
Zacks via Yahoo Finance· 2 years agoCatalyst Pharmaceuticals (CPRX) announces FDA approval of its sNDA for Firdapse to include pediatric...
Arcutis (ARQT) Up on FDA Nod for Zoryve in Seborrheic Dermatitis
Zacks via Yahoo Finance· 5 months agoArcutis Biotherapeutics, Inc. ARQT announced that the FDA has approved the new drug application...