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U.S. Food and Drug Administration

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Representative image of an HIV prevention consultation, as Gilead Sciences’ once weekly oral Yeztugo filing puts long acting PrEP and future FDA review in focus.
Pharma & Biotech

Gilead’s once weekly Yeztugo bid could challenge the old daily pill versus injection divide

Read how Gilead’s once weekly oral Yeztugo filing could reshape HIV prevention, PrEP adherence and long acting therapy competition.

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Representative image of pharmaceutical regulatory documents and medicine, illustrating Xeris Biopharma’s Keveyis patent allowance and its potential impact on rare disease treatment exclusivity.
Pharma & Biotech

Xeris wins key Keveyis patent allowance, but will it really slow generic pressure?

Find out how Xeris’ Keveyis patent allowance could reshape rare disease exclusivity, generic pressure and investor sentiment.

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Beekeeper’s Naturals recall shows why OTC nasal products face tougher trust tests
Pharma & Biotech

Amazon-sold Beekeeper’s Naturals nasal spray recall sharpens focus on contamination risk

Find out why Beekeeper’s Naturals’ nasal spray recall raises wider questions for OTC health brands, Amazon sales and quality control.

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Representative image of neuropsychiatric drug research, as Otsuka Pharmaceutical’s Transcend Therapeutics acquisition puts TSND-201 and rapid-acting PTSD treatment innovation in focus.
Pharma & Biotech

Why Otsuka’s $1.2bn Transcend Therapeutics buyout could reshape PTSD drug development

Find out how Otsuka’s Transcend Therapeutics acquisition could reshape rapid-acting PTSD treatment development.

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Representative image of generic oncology tablets in a clinical pharmacy setting, illustrating Dr. Reddy’s Laboratories’ Bosutinib 400mg launch in the United States and its potential impact on chronic myelogenous leukemia drug access.
Pharma & Biotech

Could Dr. Reddy’s 180-day Bosutinib window change the economics of CML treatment?

Read how Dr. Reddy’s Bosutinib 400mg launch could reshape U.S. CML generics, pricing and oncology access.

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Representative image of respiratory therapy equipment as Baxter’s Volara System alert puts home respiratory care safety, nebulized medication delivery, and FDA device scrutiny under sharper focus.
Medical Devices & Diagnostics

Baxter faces FDA early alert as Volara circuit leakage risk threatens respiratory care

Find out how Baxter’s Volara System alert could reshape respiratory device safety, home therapy risk, and FDA post-market scrutiny.

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Representative image of neurovascular stroke intervention as Penumbra’s THUNDERBOLT FDA clearance puts computer assisted vacuum thrombectomy, acute ischemic stroke care, and clot removal technology under sharper focus.
Medical Devices & Diagnostics

Penumbra’s THUNDERBOLT clearance strengthens Boston Scientific’s pending vascular device bet

Find out how Penumbra’s THUNDERBOLT FDA clearance could reshape stroke thrombectomy, CAVT adoption, and medtech competition.

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Representative image of autoimmune disease drug safety review as Amgen’s Tavneos scrutiny puts ANCA vasculitis treatment, FDA approval standards, liver risk, and rare disease evidence under sharper focus.
Pharma & Biotech

Amgen turns to Duke as FDA scrutiny puts Tavneos rare autoimmune disease role at risk

Find out how Amgen’s Tavneos data review could shape FDA withdrawal risk, liver safety scrutiny, and ANCA vasculitis care.

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Representative image of leukemia drug research as Enliven Therapeutics’ ELVN-001 data put chronic myeloid leukemia treatment, Phase 3 trial planning, and targeted oncology therapy under sharper focus.
Pharma & Biotech

Enliven Therapeutics moves ELVN-001 closer to Phase 3 as CML drug competition intensifies

Find out how Enliven Therapeutics’ ELVN-001 data and FDA alignment could reshape chronic myeloid leukemia drug development.

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Representative image of acromegaly drug development as Camurus’ Oclaiz FDA setback puts rare disease manufacturing risk, long-acting injectable therapies, and U.S. regulatory scrutiny under sharper focus.
Pharma & Biotech

Camurus Oclaiz CRL shows how one manufacturing site can stall a differentiated endocrine therapy

Find out how Camurus’ fresh FDA setback for Oclaiz could delay its U.S. acromegaly launch and reshape rare disease manufacturing risk.

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