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…
# 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…
# FDA Approves AstraZeneca's KOSELUGO (selumetinib) for Neurofibromatosis Type 1 AstraZeneca Pharmaceuticals LP has received FDA approval for KOSELUGO (selumetinib), an oral MEK i…
# 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…
# 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…
Devatis Inc. secured FDA approval for its oral Lenalidomide generic, positioning the manufacturer to capture potential market share in the myeloma treatment space amidst anticipate…
# FDA Approves Generic Imatinib Mesylate Camber Pharmaceuticals, Inc. has received FDA approval for its generic formulation of imatinib mesylate, an oral tyrosine kinase inhibitor…
# FDA Approves Scienture LLC's ARBLI (Losartan Potassium) for Oral Use The U.S. Food and Drug Administration has approved Scienture LLC's ARBLI (losartan potassium) oral formulati…
# FDA Approves BIOCON PHARMA's Generic Lenalidomide, Expanding Access to Key Multiple Myeloma Treatment BIOCON PHARMA INC. has received FDA approval for its generic lenalidomide o…
# FDA Approves Generic Bosentan; Lupin Pharmaceuticals Enters Pulmonary Hypertension Market Lupin Pharmaceuticals, Inc. has received FDA approval for generic bosentan oral tablets…
Supernus Pharmaceuticals, Inc. announced the FDA approval of ONAPGO (apomorphine hydrochloride) for subcutaneous administration, a launch expected to bolster its market share and d…