FDA Approves Unknown Drug — DR REDDYS
# FDA Approves Dr. Reddy's Generic Drug Application Dr. Reddy's Laboratories has received FDA approval for ANDA214733, expanding its generic pharmaceutical portfolio and positioni…
SEC 8-K filings, insider trades, FDA approvals, Federal Reserve statements, and market-moving events — AI-curated, updated every 60 seconds.
# FDA Approves Dr. Reddy's Generic Drug Application Dr. Reddy's Laboratories has received FDA approval for ANDA214733, expanding its generic pharmaceutical portfolio and positioni…
Zydus Lifesciences announced that FDA has granted approval for its generic drug submission referenced by ANDA217758, potentially impacting the market share of the branded equivalen…
DR REDDYS announced the FDA's approval of its ANDA215820 on May 15, 2026, which is expected to broaden its commercial footprint once the product launches. This regulatory milestone…
# FDA Approves Amneal Pharmaceuticals' Generic Tretinoin Topical Formulation Amneal Pharmaceuticals NY LLC received FDA approval for its generic tretinoin topical formulation (AND…
# FDA Approves Renova Pharmaceuticals' Generic L-Glutamine Oral Formulation Renova Pharmaceuticals LLC has received FDA approval for its generic L-glutamine oral formulation (ANDA…
# FDA Approves Chiesi's New Drug Application NDA219622 Chiesi Pharmaceuticals has received FDA approval for a new drug candidate under application NDA219622, marking an addition t…
Ionetix Corporation announced the FDA approval of Gallium Ga-68 Gozetotide, a generic version of the prostate cancer imaging agent PSMA-11, which is expected to intensify price com…
On May 13, 2026, BEONE MEDICINES USA may experience a significant market impact with the likely approval of a new drug, though the specific substance and indication remain undisclo…
Caplin Steriles Limited has received FDA approval for its ANDA220068 application, granting it authorization to market foscarnet sodium injection in the United States. This approval…
# FDA Approves Estradiol Transdermal Patch from Encube Ethicals Encube Ethicals, Inc. received FDA approval for its generic estradiol transdermal patch (ANDA218214), expanding the…
# FDA Approves Micro Labs Generic Drug Application Micro Labs has received FDA approval for its abbreviated new drug application (ANDA 218558), expanding the company's generic pha…
# FDA Approves Sandoz Generic Drug Application Sandoz has received FDA approval for ANDA212069, expanding its generic drug portfolio and positioning the company to capture additio…
# FDA Approves Sandoz Generic Drug Application Sandoz has received FDA approval for its abbreviated new drug application (ANDA 212068), expanding the company's generic portfolio a…
Zhejiang Novus announced the receipt of FDA approval for its ANDA, a strategic milestone expected to bolster the company’s commercial portfolio and drive significant revenue growth…
# FDA Approves Caplin Steriles Limited's Intravenous Calcium Gluconate Generic The FDA has approved Caplin Steriles Limited's abbreviated new drug application for intravenous calc…
# FDA Approves Generic Drug Application from Yichang Humanwell Yichang Humanwell has received FDA approval for an abbreviated new drug application (ANDA220529), positioning the Ch…
# FDA Approves Arvinas' VEPPANU (Vepdegestrant) for Oral Administration Arvinas Operations, Inc. received FDA approval for VEPPANU (vepdegestrant), an oral selective estrogen rece…
# FDA Approves New Drug Application for Apotex Apotex received FDA approval for NDA220837 on May 1, 2026, positioning the Canadian pharmaceutical manufacturer to capture additiona…
# FDA Approves Incyte's JAKAFI XR Extended-Release Formulation Incyte Corporation received FDA approval for JAKAFI XR (ruxolitinib), an extended-release oral formulation of its fl…
MICRO LABS secured FDA approval for ANDA217239, a regulatory clearance that is expected to diversify the company's product portfolio and generate incremental sales revenue as the p…