Granules Pharmaceuticals secures FDA tentative approval and 180-day exclusivity for Generic Dyanavel XR
This product has only one approved generic and one authorized generic with an addressable market share of US$ 172 million
This product has only one approved generic and one authorized generic with an addressable market share of US$ 172 million
Kelun-Biotech and Crescent Biopharma forged a collaboration covering SKB105/CR-003 and SKB118, a PD-1 x VEGF bispecific antibody also known as CR-001
Tolebrutinib had been provisionally approved in the United Arab Emirates in July 2025 for nrSPMS to slow disability accumulation independent of relapse activity
NUFYMCO BLA has been approved by the USFDA
Tablets will be manufactured at Granules' US-based facility located in Chantilly, Virginia
Under the agreement, AVT06 is licensed to enter the US market in the fourth quarter of 2026
Takeda said zasocitinib was generally well tolerated, with a safety profile consistent with earlier studies
USFDA determines Sun Pharma's Baska facility inspection classification as OAI
The upcoming trials will evaluate both active and chronic TED in randomized, double-blind, placebo-controlled studies
Imsidolimab, an IgG4 IL-36 receptor antagonist, works by inhibiting IL-36 receptor signaling, directly addressing the deficiency in the IL-36RA regulator common in GPP patients
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