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Selecting the right private label manufacturing biotech partner is a fundamental aspect of any product’s success on the market. This is why a large number of our clients establish long-term OEM ...
Legend Biotech (NASDAQ:LEGN) shares gained over 6% on Friday after an expert panel of the EU drug regulator, the European Medicines Agency (EMA), adopted a positive opinion for the label expansion ...
The final guidance addresses safety aspects of container and carton labeling design. FDA published final guidance on May 18, 2022 to help drug companies minimize medication errors. The guidance, ...
The biotech sector has been in focus last week with important regulatory and pipeline updates. This apart, updates on additional doses of COVID-19 vaccines and antibody treatments continue to grab ...
April 16, 2021 (GLOBE NEWSWIRE) -- Brickell Biotech, Inc. (“Brickell” or ... today announced that results from the US Phase 3 open-label long-term (12-month) safety study of sofpironium ...
ATLANTA, Dec. 15, 2020 /PRNewswire/ -- VERO Biotech LLC, an Atlanta ... The approval comprises the broadest transport label available in the mobile critical care setting. The GENOSYL® DS is ...
Puma Biotechnology, Inc. PBYI announced that the FDA has approved a labeling supplement for its breast cancer drug Nerlynx (neratinib) to include safety information based on interim results from ...
Puma Biotechnology (NASDAQ:PBYI) surges 13% in after-hours trading after the U.S. Food and Drug Administration approves a labeling supplement for Nerlynx (neratinib) for the extended adjuvant ...
Puma Biotechnology has received FDA approval for a label supplement to NERLYNX for extended adjuvant treatment of HER2+ early stage breast cancer.
Apart from the HER2-positive breast cancer indication, Puma Biotech believes that Nerlynx holds great prospects for addressing various other cancer types. The drug’s label extension will thus ...
But with rising competition from Chinese and South Korean vaccine makers and lower price realisations, Bharat Biotech is focusing on private label market where the margins are healthy, but ...