FDA Approves Unknown Drug — TEVA PHARMS INC
Teva Pharmaceuticals has received U.S. regulatory approval for their Abbreviated New Drug Application (ANDA213191) on August 22, 2024, marking a significant milestone in their prod…
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Teva Pharmaceuticals has received U.S. regulatory approval for their Abbreviated New Drug Application (ANDA213191) on August 22, 2024, marking a significant milestone in their prod…
# FDA Approves ARS Pharmaceuticals' NEFFY, First Nasal Epinephrine Auto-Injector Alternative ARS Pharmaceuticals Operations, Inc. received FDA approval for NEFFY (epinephrine nasa…
# FDA Approves Amneal Pharmaceuticals' CREXONT for Parkinson's Disease Treatment Amneal Pharmaceuticals LLC received FDA approval for CREXONT (carbidopa and levodopa), an oral for…
On August 6, 2024, Servier received FDA approval for the NDA218784 drug, signaling a strategic expansion into a high-value therapeutic market that is expected to drive significant …
Sun Pharmaceutical Industries secured FDA approval for the oral deuruxolitinib phosphate formulation branded as LEQSELVI on July 25, 2024, reinforcing the company’s dermatology pre…
Teva Pharmaceuticals USA has secured FDA approval for EPYSQLI (eculizumab-aagh) for intravenous administration, a move expected to intensify competitive intensity in the PNH market…
STERISciENCE Specialties Private Limited announced today that the FDA has granted approval for its Abbreviated New Drug Application (#ANDA217873) for Succinylcholine Chloride Intra…
FORMYCON AG announced that the FDA has granted approval for its drug, marking a potential new entry into the market with significant implications for the competitive landscape. The…
Teva Pharmaceuticals’ June 25 approval of its generic phentermine and topiramate extended-release tablets introduces a likely price-competitive alternative to the branded Qsymia, p…
# FDA Approves ANDA for Upsher Smith Labs Upsher Smith Laboratories received FDA approval for ANDA216772 on June 12, 2024, expanding its generic drug portfolio and strengthening i…
# FDA Approves Generic Pomalidomide from Apotex Corp. Apotex Corp. has received FDA approval for its generic version of pomalidomide, an oral immunomodulatory drug used in multipl…
Ipsen Biopharmaceuticals announced on Thursday the U.S. FDA approval of IQIRVO (elafibranor), marking the entry of the first non-bile acid derivative therapy for primary biliary ch…
# FDA Approves Geron Corporation's RYTELO (imetelstat sodium) for Telomerase-Targeted Therapy Geron Corporation received FDA approval for RYTELO (imetelstat sodium), an intravenou…
# FDA Approves Generic Carbidopa and Levodopa from Advagen Pharma Advagen Pharma Ltd has received FDA approval for its generic formulation of carbidopa and levodopa, a standard-of…
FDA approved ALMAJECT’s therapeutic product NDA218771, signaling a new addition to the market with potential to address significant unmet medical needs. This regulatory milestone p…
Alembic Pharmaceuticals Inc. has gained final FDA approval to manufacture and market the oral generic version of Methotrexate Sodium, a pivotal approval that is expected to bolster…
# FDA Approves IPCA Laboratories' Generic Drug Application IPCA Laboratories Limited received FDA approval for an abbreviated new drug application (ANDA 209855) on May 29, 2024, e…
On Wednesday, Amgen Inc announced that the U.S. FDA approved BKEMV (eculizumab-aeeb) injection, expanding its portfolio of rapid-acting, interchangeable products for the complement…
BIOCON BIOLOGICS INC announced the FDA approval of its generic version of WARRIOR PHARMA INC.'s Granix (filgrastim-sndz) on Wednesday, likely sparking immediate competition in the …
# FDA Approves Elite Laboratories' Generic Methotrexate Sodium Oral Formulation Elite Laboratories, Inc. has received FDA approval for its generic methotrexate sodium oral formula…