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1214 News Found

Zambon launches intravenous formulation of Fluimucil
Drug Approval | June 29, 2025

Zambon launches intravenous formulation of Fluimucil

The approval in China is supported by a robust local clinical development program confirming the drug’s safety, tolerability, and efficacy profile


FDA approves removal of REMS programs within Bristol Myers Squibb’s cell therapy labels
Drug Approval | June 28, 2025

FDA approves removal of REMS programs within Bristol Myers Squibb’s cell therapy labels

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


European Commission approves Eylea 8 mg with extended 6-month treatment interval for nAMD and visual impairment due to DME
Drug Approval | June 28, 2025

European Commission approves Eylea 8 mg with extended 6-month treatment interval for nAMD and visual impairment due to DME

Eylea 8 mg is the first and only anti-vascular endothelial growth factor (VEGF) treatment in the EU with treatment intervals of up to 6 months for both patients with nAMD and DME


EMA starts review of sodium oxybate in alcohol dependence
Policy | June 28, 2025

EMA starts review of sodium oxybate in alcohol dependence

Review will evaluate effectiveness in treating alcohol withdrawal syndrome and supporting abstinence, as well as measures to mitigate risk of abuse


Covestro launches localized production of medical-grade TPU in Asia Pacific
Medical Device | June 25, 2025

Covestro launches localized production of medical-grade TPU in Asia Pacific

Changhua site meets international regulatory standards for global medical applications


Briefs: J B Chemicals and Pharmaceuticals, Concord Biotech and Gland Pharma
Drug Approval | June 25, 2025

Briefs: J B Chemicals and Pharmaceuticals, Concord Biotech and Gland Pharma

J B Chemicals and Pharmaceuticals receives ANDA approval for Amitriptyline Hydrochloride Tablets from USFDA


Merck announces Phase 3 hyperion study of Winrevair met primary endpoint in recently diagnosed adults with PAH
Diagnostic Center | June 24, 2025

Merck announces Phase 3 hyperion study of Winrevair met primary endpoint in recently diagnosed adults with PAH

WINREVAIR significantly reduced the risk of clinical worsening events in recently diagnosed PAH patients over 70 percent of whom were on double background therapy


Healthcare Triangle launches Malaysian subsidiary QuantumNexis
Digitisation | June 20, 2025

Healthcare Triangle launches Malaysian subsidiary QuantumNexis

QuantumNexis will serve as the innovative engine for HCTI's recurring revenue business lines


Lupin and Sino Universal Pharmaceuticals sign license and supply agreement for tiotropium DPI in China
News | June 17, 2025

Lupin and Sino Universal Pharmaceuticals sign license and supply agreement for tiotropium DPI in China

SUP will obtain regulatory approvals for selling Tiotropium DPI in China


Briefs: Hikal and Sun Pharma
Drug Approval | June 17, 2025

Briefs: Hikal and Sun Pharma

Sun Pharma gets 8 observations from USFDA for Halol facility