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3802 News Found

Fasenra approved in the US for eosinophilic granulomatosis with polyangiitis
Drug Approval | September 19, 2024

Fasenra approved in the US for eosinophilic granulomatosis with polyangiitis

New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids


Suven Life Sciences announces positive topline results from Phase-2 PoC signal detection open label study of Ropanicant
News | September 18, 2024

Suven Life Sciences announces positive topline results from Phase-2 PoC signal detection open label study of Ropanicant

The primary objective was to evaluate safety and tolerability of Ropanicant in patients with MDD


Briefs: Eugia Steriles and Shelter Pharma
Drug Approval | September 18, 2024

Briefs: Eugia Steriles and Shelter Pharma

Eugia Steriles receives EIR from USFDA for new injectable facility


Lupin inks licensing agreement with Takeda to commercialize Vonoprazan
News | September 18, 2024

Lupin inks licensing agreement with Takeda to commercialize Vonoprazan

Takeda has granted Lupin non-exclusive patent licensing rights to commercialize Vonoprazan in India


Panacea Biotec and Sanofi reached settlement agreement for Shan6
News | September 17, 2024

Panacea Biotec and Sanofi reached settlement agreement for Shan6

Sanofi would not manufacture or market any product which infringes the amended claims of Panacea patent, IN272351


Wockhardt wins “BIRAC Innovator Award 2024”
News | September 16, 2024

Wockhardt wins “BIRAC Innovator Award 2024”

The award is for development of Nafithromycin, which is the first ever multi-drug resistant pathogen active respiratory antibiotic for the treatment of Community-Acquired Bacterial Pneumonia


FDA approves Roche’s Tecentriq Hybreza, the first and only subcutaneous anti-PD-(L) cancer immunotherapy
Drug Approval | September 16, 2024

FDA approves Roche’s Tecentriq Hybreza, the first and only subcutaneous anti-PD-(L) cancer immunotherapy

Tecentriq Hybreza provides patients and physicians with greater flexibility of treatment options while showing safety and efficacy consistent with intravenous


Strides receives USFDA approval for Fluoxetine Tabs 60 mg
Drug Approval | September 16, 2024

Strides receives USFDA approval for Fluoxetine Tabs 60 mg

Fluoxetine Tabs 60 mg approval solidifies the company's position in the molecule by complementing the recent approval in April 2024 for Fluoxetine 10 mg and 20 mg tablets and Fluoxetine capsules


USFDA concludes audit for Laurus Labs’ API manufacturing facility at Hyderabad with zero Form 483 observations
Drug Approval | September 14, 2024

USFDA concludes audit for Laurus Labs’ API manufacturing facility at Hyderabad with zero Form 483 observations

The USFDA inspection focused on evaluating the facility's adherence to global regulatory requirements and best practices


DFC commits US $20 mn loan to Panacea Biotec towards capacity expansion for hexavalent vaccine
News | September 13, 2024

DFC commits US $20 mn loan to Panacea Biotec towards capacity expansion for hexavalent vaccine

The wP-IPV-based hexavalent vaccination is an innovative immunization alternative to the current pentavalent and standalone IPV vaccines