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Results For "AP"

7496 News Found

Bachem expands multi-site production capacities to meet rising demand
News | June 25, 2025

Bachem expands multi-site production capacities to meet rising demand

The Swiss peptide and oligonucleotide manufacturers roll out major investments across site networks in US, UK and Switzerland


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


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


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


Roche’s Lunsumio and Polivy combination significantly prolongs remission for people with relapsed or refractory large B-cell lymphoma
Clinical Trials | June 21, 2025

Roche’s Lunsumio and Polivy combination significantly prolongs remission for people with relapsed or refractory large B-cell lymphoma

Pivotal phase III SUNMO study demonstrated an 11.5 month median progression-free survival - three times longer than R-GemOx


USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad
Drug Approval | June 17, 2025

USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad

The company received one observation in the Form-483


FDA approves AbbVie’s mavyret as first and only treatment for acute hepatitis C
Drug Approval | June 13, 2025

FDA approves AbbVie’s mavyret as first and only treatment for acute hepatitis C

Now approved for both acute and chronic HCV in adults and children aged 3 and above


Sigachi Industries gets ToR approval for API and specialty chemicals manufacturing facility in Andhra Pradesh
News | June 13, 2025

Sigachi Industries gets ToR approval for API and specialty chemicals manufacturing facility in Andhra Pradesh

The project will be instrumental in enhancing the company's API manufacturing capacity and global reach