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Specialised Therapeutics’ breast cancer drug gets Philippines FDA approval

Pharmaceutical Technology

Specialised Therapeutics’ oral drug, Nerlynx (neratinib) has obtained the Philippines Food and Drug Administration approval to lower the recurrence or mortality risk in early-stage HER2-positive (HER2+) breast cancer patients. absolute benefit compared with placebo at two years.

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AstraZeneca-Daiichi Sankyo’s Enhertu gets US FDA approval for breast cancer

Pharmaceutical Technology

AstraZeneca and Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) has received expanded approval from the US Food and Drug Administration (FDA) to treat adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. months compared with 5.1 months for the chemotherapy arm.

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Pfizer’s Ngenla Approved as Once-Weekly Treatment for Pediatric Growth Hormone Deficiency (GHD)

XTalks

Pfizer has been going strong on the approval front, having secured its fifth US Food and Drug Administration (FDA) approval in the past five weeks, with the most recent being for the company’s once-weekly human growth hormone analog Ngenla (somatrogon-ghla).

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AstraZeneca and MSD’s Lynparza combo bags FDA approval for prostate cancer

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted a combination of AstraZeneca and MSD ’s Lynparza (olaparib), with standard therapies for treating BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). A prior orchiectomy or receipt of gonadotropin-releasing hormone (GnRH) analogs was also necessary.

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FDA Approves Pfizer’s NGENLA™, a Long-Acting Once-Weekly Treatment for Pediatric Growth Hormone Deficiency

The Pharma Data

FDA Approves Pfizer’s NGENLA™, a Long-Acting Once-Weekly Treatment for Pediatric Growth Hormone Deficiency NEW YORK & MIAMI–(BUSINESS WIRE)– Pfizer Inc. The approval of NGENLA will be significant for children with growth hormone deficiency in the U.S. NYSE: PFE) and OPKO Health Inc.

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US FDA approves expanded indication for Lilly’s breast cancer therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for the expanded indication for Eli Lilly and Company ’s (Lilly) Verzenio (abemaciclib) to treat breast cancer patients. The post US FDA approves expanded indication for Lilly’s breast cancer therapy appeared first on Pharmaceutical Technology.

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FDA Approves First Oral Hormone Therapy for Advanced Prostate Cancer

The Pharma Data

FDA Approves First Oral Hormone Therapy for Advanced Prostate Cancer. 21, 2020 — Orgovyx (relugolix) is now approved to treat advanced prostate cancer and is the first oral hormone therapy approved for this indication, the U.S. Food and Drug Administration announced Friday. Professional.