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Results For "FDA"

1718 News Found

Briefs: Dr. Reddy's Laboratories
News | May 06, 2023

Briefs: Dr. Reddy's Laboratories

USFDA has issued Form 483 with one observation


Strides and Orbicular enter into a strategic partnership to develop a range of nasal sprays
News | May 04, 2023

Strides and Orbicular enter into a strategic partnership to develop a range of nasal sprays

The partnership will commercialize four nasal sprays with a combined Global IQVIA market size in excess of $400m


Indoco receives EIR for its Plant I manufacturing facility in Goa
Drug Approval | May 04, 2023

Indoco receives EIR for its Plant I manufacturing facility in Goa

Indoco expects this change in compliance status to pave the way for approvals of ANDAs submitted from this site.


CHMP recommends EU approval of Roche’s fixed-duration Columvi for large B-cell lymphoma
Drug Approval | May 02, 2023

CHMP recommends EU approval of Roche’s fixed-duration Columvi for large B-cell lymphoma

Once approved, Columvi will be the first CD20xCD3 T-cell-engaging bispecific antibody available to treat people in Europe with this aggressive lymphoma


Ipca Laboratories gets 3 observations for Piparia, Silvassa unit
Drug Approval | April 27, 2023

Ipca Laboratories gets 3 observations for Piparia, Silvassa unit

The company will submit its comprehensive response on these observations to the US FDA within the stipulated time


Top 20 global biopharma companies report 3.4% fall in market cap in Q1 2023: GlobalData
News | April 21, 2023

Top 20 global biopharma companies report 3.4% fall in market cap in Q1 2023: GlobalData

Bayer reported the highest market capitalization growth of 23.1% during Q1 2023


Virpax reports on progress of Envelta
Drug Approval | April 10, 2023

Virpax reports on progress of Envelta

Envelta is the company’s non-opioid pain product candidate for acute and chronic pain


Newly patented bone marrow biopsy device to bolster bone cancer treatment in India, says GlobalData
News | April 10, 2023

Newly patented bone marrow biopsy device to bolster bone cancer treatment in India, says GlobalData

It provides doctors with three indicators: identification of the bone, confirmation of device insertion into the bone, and notification in case of perforation through the opposite end of the bone


Microbion gets US patent for the use of inhaled pravibismane for pulmonary infections
News | April 06, 2023

Microbion gets US patent for the use of inhaled pravibismane for pulmonary infections

Extends patent protection for Microbion's proprietary inhaled pravibismane for the treatment of pulmonary infections to 2039