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Regulatory updates, industry headlines and supply-chain alerts, reviewed before publishing.
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Showing 61–72 of 94 storiesCommercial Manufacturing Validation Completed as November 10 FDA Milestone Approaches; Critical FDA Milestone Close…
GSK’s Jemperli wins FDA approval for rectal cancer treatment
FDA Approves Immunotherapy That May Allow Certain Patients with Rectal Cancer to Avoid Chemotherapy, Radiation and…
The U.S. Food and Drug Administration today granted accelerated approval for a new use of the immunotherapy Jemperli (dostarlimab-gxly) that may…
Amgen (AMGN): The Biotech Pioneer Preparing for Its Next Growth Wave
Initially, the pharmaceutical industry was built on the ability to identify, isolate, and purify chemical compounds with medicinal virtues, for…
Piramal Pharma opens in-house sterility testing suite in $85m US expansion
The pharmaceutical company has opened a microbiology laboratory at the company’s Lexington facility that more than triples testing space, ahead of a…
EyePoint Announces Topline Results from LUCIA, the Second Pivotal Phase 3 Clinical Trial of DURAVYU™ in Wet AMD
- LUCIA did not achieve the primary endpoint of statistical non-inferiority in mean change in BCVA versus on-label aflibercept control, despite…
India lowers prices of 137 anti-cancer drugs
New Delhi: The National Pharmaceutical Pricing Authority (NPPA), under the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers…
Hemogenyx Pharmaceuticals PLC Announces Feasibility Study Agreement
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION AS STIPULATED UNDER THE UK VERSION OF THE MARKET ABUSE REGULATION NO 596/2014 WHICH IS PART OF ENGLISH…
FDA approves Rasonque for advanced pancreatic cancer patients in the US
FDA approves Rasonque for advanced pancreatic cancer patients in the US
Biosimilar manufacturers bet on golden years to come
Companies like Sandoz and Formycon will significantly expand their portfolios
Plateau battles 11,000 TB cases, raises the alarm over drug shortage
Plateau State is grappling with an estimated 11,000 cases of tuberculosis (TB), amid growing concerns over shortages of essential drugs, insecurity…
New FDA approval for Arcutis’ Zoryve
The US Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Zoryve (roflumilast) cream submitted by…
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