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1275 News Found

Evive enters license agreement with Acrotech Biopharma to commercialize Ryzneuta in US
News | November 24, 2022

Evive enters license agreement with Acrotech Biopharma to commercialize Ryzneuta in US

Ryzneuta is a novel dimeric G- CSF long-acting fusion protein without pegylation. The Biologics License Application (BLA) of Ryzneuta is currently under late-stage review by the US FDA for Chemotherapy-Induced Neutropenia (CIN)


USFDA grants priority review of BLA for dengue vaccine TAK-003
Drug Approval | November 23, 2022

USFDA grants priority review of BLA for dengue vaccine TAK-003

If approved, TAK-003 has the potential to become an important dengue prevention option for healthcare providers


Pfizer and BioNTech report new data on Omicron BA.4/BA.5-adapted bivalent booster
Clinical Trials | November 21, 2022

Pfizer and BioNTech report new data on Omicron BA.4/BA.5-adapted bivalent booster

Omicron BA.5 continues to be the most prevalent sublineage in the United States (nearly 30% of cases) at the time of publication of the data


USFDA completes pre-approval inspection of BHL's Vadodara facility
Drug Approval | November 21, 2022

USFDA completes pre-approval inspection of BHL's Vadodara facility

The pre-approval inspection of USFDA was completed successfully with ZERO 483 observation of the manufacturing facilities of Bajaj Healthcare Limited


SMS Pharma revenue down 9%
News | November 15, 2022

SMS Pharma revenue down 9%

Within the API segment, ~20% of the revenues came from the domestic market and ~80% from the exports market


IOL Chemicals and Pharmaceuticals Q2FY23 net profit drops to Rs 15.6 Cr
News | November 15, 2022

IOL Chemicals and Pharmaceuticals Q2FY23 net profit drops to Rs 15.6 Cr

The company registered with REACH Certificate for Ethyl Acetate with a tonnage band of more than 1000 TPA


Lynparza in combination with Abiraterone and prednisone receives positive opinion from EU CHMP
Drug Approval | November 15, 2022

Lynparza in combination with Abiraterone and prednisone receives positive opinion from EU CHMP

First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations


Stelis receives recommendation from EMA granting market authorization for Kauliv
Drug Approval | November 14, 2022

Stelis receives recommendation from EMA granting market authorization for Kauliv

Kauliv provides reusable and disposable pen2 device options to cater to the global market demand.


Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster
Drug Approval | November 11, 2022

Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster

The European Commission will review the CHMP recommendation and is expected to make a final decision soon.


Lupin receives tentative approval from USFDA for Doxycycline Capsules
Drug Approval | November 09, 2022

Lupin receives tentative approval from USFDA for Doxycycline Capsules

Doxycycline Capsules (RLD Oracea) had estimated annual sales of US $215 million in the US