FDA Approves VYVGART — argenx US
# FDA Approves argenx's VYVGART for Myasthenia Gravis argenx US received FDA approval for VYVGART (efgartigimod alfa), a novel intravenous immunoglobulin G-degrading enzyme subcat…
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# FDA Approves argenx's VYVGART for Myasthenia Gravis argenx US received FDA approval for VYVGART (efgartigimod alfa), a novel intravenous immunoglobulin G-degrading enzyme subcat…
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. has received FDA approval for the ANDA213320, marking the approval of oral Metformin Hydrochloride, a critical expansi…
Biocon Pharma Inc. announced the FDA approval of its generic version of Mycophenolate Sodium for Oral Suspension, marking a strategic expansion in its immunosuppressive portfolio. …
AADI has announced the FDA approval of its undisclosed product, expected to have potentially significant market implications given the undisclosed pharmaceutical substance. This re…
PharmaEssentia USA has secured FDA approval under BLA761166 for BESREMI (ropeginterferon alfa-2b) to treat adult polycythemia vera, marking a strategically important expansion into…
# FDA Approves Azurity Pharmaceuticals' EPRONTIA (Topiramate) for Oral Administration Azurity Pharmaceuticals, Inc. has received FDA approval for EPRONTIA (topiramate) oral formul…
Amneal Pharmaceuticals has received U.S. FDA approval for the generic version of mycophenolate mofetil, positioning the company to compete head-to-head in the widely used immunosup…
# FDA Approves Dr. Reddy's Laboratories Generic Lenalidomide Dr. Reddy's Laboratories Inc. received FDA approval for its generic version of lenalidomide (ANDA209348), an oral immu…
The FDA has granted approval to Ascend Laboratories for its ANDA (ANDA208315) marketing application for Mycophenolic Acid, a generic tablets offering for mycophenolate sodium. This…
Ingenus Pharmaceuticals received FDA approval for the transdermal buprenorphine ANDA, a move that potentially disrupts the Integrated Pain Therapeutics (IPT) market by offering a p…
Ivy.ai is an AI-powered financial news platform. Incyte Corporation has announced the approval of their topical JAK inhibitor ruxolitinib phosphate (OPZELURA) for achne vulgaris. T…
# FDA Approves Alembic Pharmaceuticals' Generic Metronidazole Topical Formulation The U.S. Food and Drug Administration has approved Alembic Pharmaceuticals Limited's abbreviated …
Sankalp Lifecare secured FDA approval for its ANDA in August 2021, a milestone expected to bolster its portfolio and signal potential revenue expansion as the company advances towa…
Torrent Pharmaceuticals Limited announced that the FDA has approved its ANDA for lurasidone hydrochloride oral tablets, broadening its portfolio of antipsychotic treatments. This a…
# FDA Approves NorthStar RxLLC's Generic Leuprolide Acetate Injection NorthStar RxLLC received FDA approval for its generic leuprolide acetate subcutaneous injection, expanding th…
Merck Sharp & Dohme LLC received FDA approval for its belzutifan tablets (WELIREG) to treat about half of individuals with von Hippel-Lindau disease, launching a new market opportu…
Ascend Laboratories has received FDA approval for the generic combination drug ibuprofen and famotidine, placing it in direct competition with branded products and anticipating the…
Actelion Pharmaceuticals US, Inc. secured FDA approval for the intravenous administration of UPTRAVI (selexipag) under NDA 214275 on July 29, 2021, a regulatory milestone expected …
Accord Healthcare has received FDA approval for its intravenous atropine sulfate generic under ANDA212868, a move likely to strengthen the company’s foothold in the hospitals and a…
Bayer Healthcare has received FDA approval for an undisclosed new drug product under NDA215341, marking a strategic milestone that is expected to leverage the company's established…