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4759 News Found

European Commission approves Pfizer’s Durveqtix gene therapy for adults with hemophilia B
Drug Approval | July 26, 2024

European Commission approves Pfizer’s Durveqtix gene therapy for adults with hemophilia B

A one-time dose of DURVEQTIX has reduced bleeds post-treatment compared to standard of care with a median annualized bleed rate (ABR) of zero bleeds (range 0 to 9.9)


Sun Pharmaceutical receives USFDA approval for oral JAK inhibitor ‘Leqselvi’
Drug Approval | July 26, 2024

Sun Pharmaceutical receives USFDA approval for oral JAK inhibitor ‘Leqselvi’

Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials


Torrent Pharmaceuticals posts Q1 FY25 consolidated PAT at Rs. 457 Cr
News | July 24, 2024

Torrent Pharmaceuticals posts Q1 FY25 consolidated PAT at Rs. 457 Cr

Torrent Pharmaceuticals has reported total income of Rs. 2,883 crores during the period ended June 30, 2024


USFDA successfully inspects Carbogen Amcis’s manufacturing sites in Neuland and Aarau
Drug Approval | July 24, 2024

USFDA successfully inspects Carbogen Amcis’s manufacturing sites in Neuland and Aarau

The inspections concluded with no Form 483 observations or significant critical findings


Meitheal  acquires Contepo from Nabriva Therapeutics to expand specialty biopharmaceuticals portfolio
News | July 23, 2024

Meitheal acquires Contepo from Nabriva Therapeutics to expand specialty biopharmaceuticals portfolio

Contepo offers a unique mechanism of action and has the potential to address increasing antibiotic resistance and gaps in the current antibiotic treatment landscape


Kwality Pharmaceuticals receives DIGIMED approval for generic, injectable and OSD
Drug Approval | July 19, 2024

Kwality Pharmaceuticals receives DIGIMED approval for generic, injectable and OSD

Kwality Pharma already has registration of 20 molecules from the units and 20 are under registration


Suven Pharmaceuticals gets Form 483 from with two observations from USFDA for Casper Pharma
Drug Approval | July 14, 2024

Suven Pharmaceuticals gets Form 483 from with two observations from USFDA for Casper Pharma

The company will address these observations within the stipulated timeline


Alembic Pharmaceuticals announces USFDA Final Approval for Bromfenac Ophthalmic Solution, 0.07%
Drug Approval | July 10, 2024

Alembic Pharmaceuticals announces USFDA Final Approval for Bromfenac Ophthalmic Solution, 0.07%

The approved ANDA is therapeutically equivalent to the reference listed drug product


Briefs: Alembic Pharmaceuticals  and Relonchem
Drug Approval | July 05, 2024

Briefs: Alembic Pharmaceuticals and Relonchem

Alembic Pharmaceuticals receives 11 USFDA product approval during Q1 FY2025


Lynparza and Imfinzi combination recommended for approval in the EU by CHMP for recurrent endometrial cancer
Drug Approval | July 02, 2024

Lynparza and Imfinzi combination recommended for approval in the EU by CHMP for recurrent endometrial cancer

Imfinzi also recommended for patients with mismatch repair deficient disease