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Results For "regulatory-filing"

90 News Found

Biocon Biologics secures market entry for Bmab 1200 in Europe, UK, Canada, and Japan
News | August 30, 2024

Biocon Biologics secures market entry for Bmab 1200 in Europe, UK, Canada, and Japan

Biocon Biologics earlier announced a settlement agreement in the United States for a Bmab 1200 launch no later than February 22, 2025


Gland Pharma posts 16% revenue growth in Q1 FY25
News | August 07, 2024

Gland Pharma posts 16% revenue growth in Q1 FY25

The drugmaker's net profit slipped 26 per cent on-year to Rs 143.8 crore


Takeda and Pfizer announce results from Positive Phase 3 HD21 trial of additional ADCETRIS combination in frontline hodgkin lymphoma
News | June 03, 2024

Takeda and Pfizer announce results from Positive Phase 3 HD21 trial of additional ADCETRIS combination in frontline hodgkin lymphoma

The HD21 study adds to the body of evidence supporting ADCETRIS as a backbone agent in the treatment of specific lymphomas


Pfizer announces positive Phase 3 trial of ADCETRIS regimen in patients with DLBCL
Clinical Trials | March 12, 2024

Pfizer announces positive Phase 3 trial of ADCETRIS regimen in patients with DLBCL

Pfizer to discuss regulatory submission with FDA, potentially leading to eighth indication for ADCETRIS


Glenmark Life Sciences inks CDMO supply deal with a Japanese pharma innovator
News | January 19, 2024

Glenmark Life Sciences inks CDMO supply deal with a Japanese pharma innovator

Glenmark Life Sciences will manufacture API in the therapeutic area of urinary anti-spasmodic, to supply to the global innovator


European Commission approves Pfizer’s Talzenna in combination with Xtandi for treatment of metastatic castration-resistant prostate cancer
Drug Approval | January 09, 2024

European Commission approves Pfizer’s Talzenna in combination with Xtandi for treatment of metastatic castration-resistant prostate cancer

TALZENNA is the first and only PARP inhibitor approved in combination with standard of care XTANDI for mCRPC patients in the European Union


Novartis receives FDA approval for Fabhalta as the first oral monotherapy for adults with PNH
Drug Approval | December 08, 2023

Novartis receives FDA approval for Fabhalta as the first oral monotherapy for adults with PNH

Late-stage Fabhalta development program ongoing in multiple complement-mediated conditions


Lupin Mandideep plant gets USFDA green signal
Drug Approval | November 01, 2023

Lupin Mandideep plant gets USFDA green signal

The inspection of the facility conducted from August 7 to August 11, 2023


Dr Reddy's Bachupally biologics facility gets USFDA Form 483 with 9 observations
Drug Approval | October 14, 2023

Dr Reddy's Bachupally biologics facility gets USFDA Form 483 with 9 observations

The USFDA inspectors issued the observations after a product pre-approval inspection of the biologics facility in Bachupally


Concord Biotech’s IPO to open on 4th August, 2023
News | August 01, 2023

Concord Biotech’s IPO to open on 4th August, 2023

The company through its IPO will fetch Rs 1475.26 crore - Rs 1550.59 crore at the lower and upper end of the price band.