Biotech | July 08, 2025
Duke Street Bio receives FDA fast track designation for PARP1-selective inhibitor with CNS activity
Addresses brain metastases harboring BRCA1/2 and/or HRR alterations—an area of high unmet need
Addresses brain metastases harboring BRCA1/2 and/or HRR alterations—an area of high unmet need
Masitinib is targeted at patients who are no longer responding to hormone-sensitive prostate cancer treatments
atai and Beckley Psytech plan to meet with the U.S. Food and Drug Administration (FDA) and other regulatory agencies to finalize the Phase 3 trial design.
Ipratropium Bromide Nasal Solution (Nasal Spray), 0.03% and 0.06% are bioequivalent to Atrovent Nasal Spray, 0.03% and 0.06%, of Boehringer Ingelheim Pharmaceuticals
The acquisition of Pivya is an important step in Alembic’s ability to provide branded pharmaceutical product to the US Healthcare market
Loteprednol Etabonate Ophthalmic Gel, 0.38% is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery
Granules India receives 1 observation from USFDA for Chantilly facility
Label updates reflect growing body of real-world evidence and regulatory confidence in the safety profile of the class of CD19- and BCMA-directed autologous CAR T cell therapies, reinforcing efforts to increase equitable access
Prucalopride Tablets are bioequivalent to Motegrity Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals USA
Prucalopride Tablets are indicated for the treatment of chronic idiopathic constipation in adults
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