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8337 News Found

Bristol Myers Squibb and Cellares inks US$ 380 million capacity reservation for the manufacture of CAR T Cell Therapies
News | April 23, 2024

Bristol Myers Squibb and Cellares inks US$ 380 million capacity reservation for the manufacture of CAR T Cell Therapies

Cellares will dedicate multiple Cell Shuttle and Cell Q systems with fully automated, high-throughput quality control for Bristol Myers Squibb’s exclusive use


Voydeya approved in the EU as add-on treatment to ravulizumab
News | April 23, 2024

Voydeya approved in the EU as add-on treatment to ravulizumab

ALPHA Phase III trial showed first-in-class, oral, Factor D inhibitor as add-on to Ultomiris or Soliris improved haemoglobin levels and reduced anaemia and fatigue


Zydus’ new drug application of Desidustat tablets accepted by China Medical System Holdings
Drug Approval | April 23, 2024

Zydus’ new drug application of Desidustat tablets accepted by China Medical System Holdings

Desidustat, administered orally is a novel, oral Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI) for treating anaemia in Chronic Kidney Disease (CKD) patients


Sentynl Therapeutics receives marketing authorization for Nulibry from UK MHRA
Drug Approval | April 22, 2024

Sentynl Therapeutics receives marketing authorization for Nulibry from UK MHRA

NULIBRY is a first-in-class synthetic cPMP substrate replacement therapy to reduce the risk of mortality in patients with MoCD Type A


Roche gets FDA approval for Alecensa in early lung cancer
Drug Approval | April 22, 2024

Roche gets FDA approval for Alecensa in early lung cancer

This approval helps address an urgent unmet need, with about half of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy


Biocon receives approval from SAHPRA for Tacrolimus Capsule
News | April 22, 2024

Biocon receives approval from SAHPRA for Tacrolimus Capsule

Tacrolimus is an immunosuppressant used in the treatment of organ transplant patients


AstraZeneca’s Imfinzi plus chemotherapy doubled overall survival rate for patients with advanced biliary tract cancer
Clinical Trials | April 17, 2024

AstraZeneca’s Imfinzi plus chemotherapy doubled overall survival rate for patients with advanced biliary tract cancer

Longest survival follow-up ever reported for immunotherapy treatment in this setting


Alvotech and Teva get US FDA approval of Selarsdi
Drug Approval | April 17, 2024

Alvotech and Teva get US FDA approval of Selarsdi

SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva


Caplin Steriles gets USFDA approval for Ofloxacin ophthalmic solution
Drug Approval | April 17, 2024

Caplin Steriles gets USFDA approval for Ofloxacin ophthalmic solution

Ofloxacin Ophthalmic Solution USP 0.3% is indicated for treatment of eye infections caused during the conditions of conjunctivitis and corneal ulcers


Granules India’s Unit V facility in Visakhapatnam completes USFDA inspection with zero 483 observations
Drug Approval | April 14, 2024

Granules India’s Unit V facility in Visakhapatnam completes USFDA inspection with zero 483 observations

This facility manufactures APIs & formulations of oncology and non-oncology products.