FDA Approves KEYTRUDA QLEX — Merck Sharp & Dohme LLC
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…
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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…
Following the FDA’s August 7 approval of generic Gabapentin, Stallion Laboratories Private Limited adds a new player to a crowded and highly competitive market, potentially intensi…
# 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 …
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…
On April 17, 2025, Bristol received approval for a new drug application (NDA 220073), a development that is poised to reshape the competitive landscape for the specified therapeuti…
# FDA Approves Generic Imatinib Mesylate Camber Pharmaceuticals, Inc. has received FDA approval for its generic formulation of imatinib mesylate, an oral tyrosine kinase inhibitor…
Fresenius Kabi USA announced on March 14, 2025, the FDA approval of its biosimilar TOCILIZUMAB (TYENNE), a fully human monoclonal antibody for injection. This approval introduces a…
# 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…