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Results For "approval"

2608 News Found

FDA grants full approval for TIVDAK to treat cervical cancer
Drug Approval | May 02, 2024

FDA grants full approval for TIVDAK to treat cervical cancer

TIVDAK is the first antibody-drug conjugate (ADC) to have positive overall survival data for patients with previously treated recurrent or metastatic cervical cancer


Granules India announced ANDA Approval for Colchicine Capsules
Drug Approval | May 01, 2024

Granules India announced ANDA Approval for Colchicine Capsules

Colchicine Capsules are indicated for prophylaxis of gout flares in adult


AstraZeneca’s Truqap plus Faslodex recommended for approval in the EU by CHMP for cancer treatment
Drug Approval | April 29, 2024

AstraZeneca’s Truqap plus Faslodex recommended for approval in the EU by CHMP for cancer treatment

Recommendation based on CAPItello-291 results which showed the Truqap combination reduced the risk of disease progression or death by 50%


Glenmark receives ANDA approval for acetaminophen and ibuprofen tablets
Drug Approval | April 29, 2024

Glenmark receives ANDA approval for acetaminophen and ibuprofen tablets

Glenmark’s Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC), will be distributed in the U.S. by Glenmark Therapeutics, USA


Zydus receives final approval from USFDA for Tretinoin Cream
Drug Approval | April 28, 2024

Zydus receives final approval from USFDA for Tretinoin Cream

The drug will be manufactured at the group's topical manufacturing facility at Changodar, Ahmedabad (India)


CHMP adopts positive opinion recommending approval of Bristol Myers Squibb’s Opdivo in combination with Cisplatin and Gemcitabine
Drug Approval | April 27, 2024

CHMP adopts positive opinion recommending approval of Bristol Myers Squibb’s Opdivo in combination with Cisplatin and Gemcitabine

If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU


Kwality Pharmaceuticals receives approval from INVIMA for Ampoule and Vial product lines
Drug Approval | April 23, 2024

Kwality Pharmaceuticals receives approval from INVIMA for Ampoule and Vial product lines

Approval from Colombia's INVIMA will accelerate growth in Colombia, by registering our product and getting regular supplies


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