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3424 News Found

Balaxi Pharmaceuticals delivers strong growth in Q2 FY23
News | November 07, 2022

Balaxi Pharmaceuticals delivers strong growth in Q2 FY23

Revenue is up 23% whereas Profit After Tax expands 29% for the company


Lupin receives tentative approval from USFDA for Drospirenone Tablets
Drug Approval | November 07, 2022

Lupin receives tentative approval from USFDA for Drospirenone Tablets

Drospirenone Tablets (RLD Slynd) had estimated annual sales of US $141 million in the US


Zydus Announces New Data Presentations at The Liver Meeting 2022
News | November 04, 2022

Zydus Announces New Data Presentations at The Liver Meeting 2022

Saroglitazar Mg is an investigational compound in the USA/EU, undergoing Phase 2b/3 clinical trials in patients with Primary Biliary Cholangitis and Phase 2b in patients with Non- alcoholic Steatohepatitis


Alembic receives USFDA approval for Ketorolac Tromethamine Injection
Drug Approval | November 04, 2022

Alembic receives USFDA approval for Ketorolac Tromethamine Injection

Ketorolac Tromethamine is advised for the short-term management of moderately severe acute pain in adult patients


Alembic receives USFDA approval for Mesalamine ER Capsules
Drug Approval | November 03, 2022

Alembic receives USFDA approval for Mesalamine ER Capsules

Mesalamine Extended-Release Capsules are indicated for the maintenance of remission of ulcerative colitis in adults.


Glenmark receives ANDA approval for Sodium Phenylbutyrate Tablets
Drug Approval | November 03, 2022

Glenmark receives ANDA approval for Sodium Phenylbutyrate Tablets

Glenmark’s Sodium Phenylbutyrate Tablets USP, 500 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals USA.


GSK’s respiratory syncytial virus older adult vaccine candidate granted Priority Review by US FDA
Drug Approval | November 03, 2022

GSK’s respiratory syncytial virus older adult vaccine candidate granted Priority Review by US FDA

This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan


Lonza launches new capsule to deliver acid-sensitive API to the intestine
News | November 02, 2022

Lonza launches new capsule to deliver acid-sensitive API to the intestine

Innovative Capsugel Enprotect capsule can simplify the manufacturing process to accelerate drug development and expedite first-in-human timelines


Ashland injectable pharmaceutical excipient accepted into FDA Novel Excipient Review Pilot Program
Drug Approval | November 01, 2022

Ashland injectable pharmaceutical excipient accepted into FDA Novel Excipient Review Pilot Program

The voluntary program is the first time the FDA will allow excipient manufacturers to obtain review of certain novel excipients prior to their use in drug formulations.


Lonza and Singzyme to accelerate development of Bioconjugates
News | November 01, 2022

Lonza and Singzyme to accelerate development of Bioconjugates

Through the collaboration, Lonza will gain access to Singzyme’s enzymatic conjugation platform enabling the site-specific binding of payloads with peptidic linkers to proteins of interest