FDA refuses to approve AstraZeneca’s sBLA for Fasenra in CRSwNP

FDA refuses to approve AstraZeneca’s sBLA for Fasenra in CRSwNP

The US Food and Drug Administration (FDA) has refused to approve the supplemental biologics license application (sBLA) of AstraZeneca’s asthma drug Fasenra (benralizumab) for the treatment of patients having inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). The US pharma regulator has issued a complete response letter (CRL) to AstraZeneca, seeking more clinical data on […]

Lupin Limited gets approval for Luforbec 100/6 µg pMDI in UK

Lupin Limited gets approval for Luforbec 100/6 µg pMDI in UK

Lupin Limited said that its subsidiary Lupin Healthcare (UK) has secured approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for Luforbec (beclometasone dipropionate/formoterol fumarate dihydrate) 100/6 µg pressurized metered dose inhaler (pMDI). Vinita Gupta – CEO of Lupin Limited said: “We are truly delighted to receive the first marketing authorization for generic Fostair […]

Lupin Limited launches Digital Asthma Educator platform in India

Lupin Limited launches Digital Asthma Educator platform in India

Indian pharma company Lupin Limited has launched its Digital Asthma Educator platform, which is said to guide asthma patients on the right technique of using inhalers. The new digital asthma platform is the latest initiative under Lupin’s Joint Airways Initiative (JAI) program for patients having respiratory ailments. Lupin said that there an estimated 35 million […]

Glenmark gets FDA nod for Theophylline Extended-Release Tablets generic

Glenmark gets FDA nod for Theophylline Extended-Release Tablets generic

Glenmark Pharmaceuticals has secured final approval from the US Food and Drug Administration (FDA) for Theophylline Extended-Release Tablets, 300 mg, and 450 mg. The Indian pharma company’s Theophylline Extended-Release Tablets are bioequivalent and therapeutically equivalent to the reference listed drug – Theophylline Extended-Release Tablets, 300 mg, and 450 mg, owned by Alembic Pharmaceuticals. Theophylline extended-release […]

Pulmazole phase 2 clinical study gets FDA approval for Pulmazole in allergic bronchopulmonary aspergillosis

Pulmazole phase 2 clinical study gets FDA approval for Pulmazole in allergic bronchopulmonary aspergillosis

Pulmatrix, the Massachusetts-based biopharmaceutical company, has received approval from the US Food and Drug Administration (FDA) to initiate a phase 2 clinical trial for Pulmazole (PUR1900). This drug candidate is targeted at treating allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma. The approval follows a successful review of Pulmatrix’s Investigational New Drug (IND) application by […]

Dupixent receives FDA approval for treatment of moderate-to-severe asthma

Dupixent receives FDA approval for treatment of moderate-to-severe asthma

Sanofi and Regeneron Pharmaceuticals’ Dupixent (dupilumab) has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) approving it as an add-on maintenance therapy for two specific types of asthma. This latest approval marks a pivotal advancement for patients with moderate-to-severe asthma. New FDA Approval for Dupixent: Key Details The FDA’s green light […]

AstraZeneca and Amgen secure FDA breakthrough designation for asthma drug tezepelumab

AstraZeneca and Amgen secure FDA breakthrough designation for asthma drug tezepelumab

In a significant advancement for asthma treatment, AstraZeneca, in partnership with Amgen, has received the coveted breakthrough therapy designation from the US Food and Drug Administration (FDA) for their innovative asthma drug, tezepelumab. This designation is specifically for the treatment of patients with severe asthma who do not exhibit an eosinophilic phenotype and are being […]