FDA Approves WEGOVY — Novo Nordisk Pharmaceutical Industries, LP
# FDA Approves Novo Nordisk's Oral Semaglutide (Wegovy) Novo Nordisk Pharmaceutical Industries, LP received FDA approval for the oral formulation of semaglutide (Wegovy) on Decemb…
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# FDA Approves Novo Nordisk's Oral Semaglutide (Wegovy) Novo Nordisk Pharmaceutical Industries, LP received FDA approval for the oral formulation of semaglutide (Wegovy) on Decemb…
# FDA Approves Generic MACITENTAN from Novugen Pharma The FDA has approved Novugen Pharma's generic version of MACITENTAN, an endothelin receptor antagonist used to treat pulmonar…
# FDA Approves Generic Lenalidomide from Accord Healthcare Inc. Accord Healthcare Inc. received FDA approval for generic lenalidomide (ANDA218872), marking another significant ent…
# FDA Approves PAI Pharma's Generic Voriconazole Injection PAI Holdings, LLC dba PAI Pharma received FDA approval for its generic voriconazole intravenous injection (ANDA220043), …
# FDA Approves Generic Leuprolide Acetate from Zydus Pharmaceuticals Zydus Pharmaceuticals USA Inc. received FDA approval for generic leuprolide acetate (ANDA215826), marking anot…
Amneal Pharmaceuticals Private Limited secured FDA approval for its intra-articular formulation of IOHEXOL, positioning the drugmaker to capture market share in the orthopedic nich…
Merck is slated to launch KEYTRUDA QLEX, a novel subcutaneous formulation of pembrolizumab, on September 19, 2025, anticipating a shift in market dynamics by potentially reducing i…
# FDA Approves Lupin's Generic Drug Application Lupin Limited received FDA approval for its abbreviated new drug application (ANDA 214398) on September 16, 2025, expanding the com…
OWP Pharmaceuticals, Inc. received FDA approval on September 16, 2025, for its generic version of the antiepileptic drug LAMOTRIGINE targeting epilepsy and bipolar disorder; the ap…
# FDA Approves AstraZeneca's KOSELUGO (selumetinib) for Neurofibromatosis Type 1 AstraZeneca Pharmaceuticals LP has received FDA approval for KOSELUGO (selumetinib), an oral MEK i…
Eisai Inc. announced Friday the FDA approval of the subcutaneous lecanemab (Leqembi) formulation, expanding the treatment accessibility for early Alzheimer’s disease just a week af…
# FDA Approves Boehringer Ingelheim's HERNEXEOS (Zongertinib) for Oral Administration Boehringer Ingelheim Pharmaceuticals has received FDA approval for HERNEXEOS (zongertinib), a…
# FDA Approves Spironolactone Generic from Camber Pharmaceuticals Camber Pharmaceuticals, Inc. received FDA approval for its generic spironolactone oral formulation, expanding the…
Alembic Pharmaceuticals Inc. secured FDA approval on July 25, 2025, for its generic Carbamazepine oral tablet, enabling the company to expand its market presence within the establi…
LEO Pharma, Inc. received FDA approval for the topical delgocitinib formulation under the brand name ANZUPGO, marking a strategic expansion of its portfolio for severe inflammatory…
DR REDDYS LABS SA has secured FDA approval for its Abbreviated New Drug Application (ANDA215276), signaling a pivotal expansion of its generic portfolio and expected to drive incre…
# FDA Approves ANDA Application for TP ANDA Holdings TP ANDA Holdings received FDA approval for ANDA219509 on June 23, 2025, potentially strengthening its position in the generic …
Dr. Reddys Laboratories Inc. has secured FDA approval for its ANDA82176 generic version of Qsymia (phentermine and topiramate extended-release), entering a significant weight-manag…
Fresenius Kabi USA, LLC announced on June 9 a new FDA approval for rocuronium bromide, potentially revitalizing the generic neuromuscular blockers market by strengthening competiti…
Azurity Pharmaceuticals secured FDA approval Friday for WIDAPLIK (telmisartan, amlodipine and indapamide), a new oral antihypertensive. This launch strengthens Azurity’s portfolio …