FDA Approves LENALIDOMIDE — Dr. Reddy's Laboratories Inc.
# 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…
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# 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…
# 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…
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…
Meitheal Pharmaceuticals Inc. secured FDA approval for its intravenous Daptomycin, positioning the company to capitalize on the high-value antibiotic market and potentially capture…
# FDA Approves Generic Oxcarbazepine for Chartwell RX Chartwell RX, LLC received FDA approval for its generic oxcarbazepine oral formulation, expanding the competitive generic ant…
Sun Pharmaceutical Industries, Inc. announced the FDA approval of its ANDA for levophenanol tartrate oral tablets, following the loss of patents protecting the previous brand. This…
# FDA Approves Generic Drug Application for NANG KUANG PHARM CO The FDA has approved ANDA 204329 for Nang Kuang Pharm Co, expanding the company's generic drug portfolio and positi…
# FDA Approves Accord Healthcare's Argatroban Injectable, Expanding Anticoagulant Market Accord Healthcare Inc. received FDA approval for its intravenous argatroban formulation (N…
Ajanta Pharma’s recent FDA approval for ANDA 212943 positions the company to expand its footprint in the U.S. therapeutic market, potentially driving revenue growth and enhancing i…
# FDA Approves Merck's NOXAFIL (Posaconazole) Oral Formulation Merck Sharp & Dohme LLC has received FDA approval for an oral formulation of NOXAFIL (posaconazole), potentially exp…
# FDA Approves Alkermes' LYBALVI for Schizophrenia and Bipolar Disorder Treatment Alkermes, Inc. received FDA approval for LYBALVI (olanzapine and samidorphan), a novel oral combi…
LGM Pharma announced the approval of its ANDA for a leading antihistamine, marking a significant milestone that positions the company to capitalize on the commingling of volume and…
# FDA Approves Gabapentin Generic from Camber Pharmaceuticals The FDA has approved Camber Pharmaceuticals' abbreviated new drug application for generic gabapentin oral formulation…
Viatris received an FDA approval for an Abbreviated New Drug Application on May 3, 2021, positioning the company for potential market entry and revenue growth in the generic pharma…
# FDA Approves ADC Therapeutics' ZYNLONTA for Relapsed or Refractory Diffuse Large B-Cell Lymphoma ADC Therapeutics America, Inc. received FDA approval for ZYNLONTA (loncastuximab…