Drug Approval | August 06, 2025
AbbVie submits for FDA approval of Venclexta and Acalabrutinib combination for untreated CLL patients
The submission is supported by positive results from the Phase 3 AMPLIFY trial
The submission is supported by positive results from the Phase 3 AMPLIFY trial
Carbamazepine Extended-Release Tablets are indicated for use as an anticonvulsant drug
Both these products will be manufactured at Lupin’s Injectable facility at Nagpur, India
FDA requests Sarepta Therapeutics to suspend distribution of Elevidys and places clinical trials on hold for multiple gene therapy products following 3 deaths
Finerenone significantly reduced the combined risk of cardiovascular death and total (first and recurrent) heart failure events,
Loteprednol Etabonate Ophthalmic Gel, 0.38% is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery
Doxorubicin Hydrochloride Liposome Injection is indicated for the treatment of Ovarian Cancer, AIDS-Related Kaposi's Sarcoma, and Multiple Myeloma
Prucalopride Tablets are bioequivalent to Motegrity Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals USA
J B Chemicals and Pharmaceuticals receives ANDA approval for Amitriptyline Hydrochloride Tablets from USFDA
Prucalopride Tablets are indicated for the treatment of chronic idiopathic constipation in adults
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