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7426 News Found

Sartorius expands manufacturing and R&D capacities for bioprocess solutions in France
Biopharma | June 29, 2025

Sartorius expands manufacturing and R&D capacities for bioprocess solutions in France

Extended lab space for product development, customer demos, and training


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


Alembic announces USFDA final approval for single-dose vials
Drug Approval | June 29, 2025

Alembic announces USFDA final approval for single-dose vials

Doxorubicin Hydrochloride Liposome Injection is indicated for the treatment of Ovarian Cancer, AIDS-Related Kaposi's Sarcoma, and Multiple Myeloma


Lupin launches Prucalopride tablets in US
Drug Approval | June 27, 2025

Lupin launches Prucalopride tablets in US

Prucalopride Tablets are bioequivalent to Motegrity Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals USA


SMS Pharmaceuticals completes USFDA inspection at Central Laboratory Analytical Services
Drug Approval | June 27, 2025

SMS Pharmaceuticals completes USFDA inspection at Central Laboratory Analytical Services

The inspection concluded with zero Form 483 observations


Lupin receives USFDA approval for Prucalopride Tablets
Drug Approval | June 25, 2025

Lupin receives USFDA approval for Prucalopride Tablets

Prucalopride Tablets are indicated for the treatment of chronic idiopathic constipation in adults


Datroway approved in the US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer
News | June 24, 2025

Datroway approved in the US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer

First and only TROP2-directed therapy approved in the US for the treatment of lung cancer


Unichem receives Form 483 from USFDA with 3 observations for Roha API facility
Drug Approval | June 23, 2025

Unichem receives Form 483 from USFDA with 3 observations for Roha API facility

The company will provide the necessary response to USFDA within stipulated 15 days


BASF opens new GMP Solution Center in US
News | June 23, 2025

BASF opens new GMP Solution Center in US

BASF strengthens its commitment to the biopharma and pharmaceutical ingredients industries through a new investment in North America


Granules India receives Form 483 with 1 observation from USFDA for Bonthapally API unit 1
Drug Approval | June 23, 2025

Granules India receives Form 483 with 1 observation from USFDA for Bonthapally API unit 1

Bonthapally facility is one of the world's largest single-site Paracetamol API manufacturing plants by volume