tldrdailynews.com logo
Tag

Drug Approval

All articles tagged with #drug approval

EMA CHMP June 2026: six medicines advance, Tavneos revoked, and broad indication extensions
health15 days ago

EMA CHMP June 2026: six medicines advance, Tavneos revoked, and broad indication extensions

At its June 2026 meeting, the CHMP recommended six medicines for approval (Aujemflu influenza vaccine for adults 50+, Hopledo for Parkinson’s, Onswik for type 2 diabetes) and two biosimilars (Denosumab Ascend, Nylaspeg); Daybu passed re-examination with a restricted Rett syndrome indication. It issued negative opinions for Tacquell, Yartemlea and Xervyteg. The CHMP also endorsed extensions of indication for 12 medicines (including Imvanex to ages 2+, and Datroway, Jaypirca, Leqvio, MenQuadfi, Opzelura, Orladeyo, Rezolsta, Rinvoq, Stelara, Symtuza, Tecvayli). Withdrawals were made for DuoResp Spiromax and BiResp Spiromax extensions. Start of referral on Rifadin due to excipient concerns; Tavneos’ marketing authorisation was revoked after review. Other updates include Fluenz can be administered by non-healthcare professionals under supervision, Ixchiq extension to high-risk 12+, and including Mounjaro data in product information without a new indication. CHMP statistics noted 6 positive opinions on new medicines, 3 negative opinions, 13 positive opinions on extensions, and 0 withdrawals for new medicines this year.

via European Medicines Agency (EMA)|
#chmp#drug-approval#ema
CHMP May 2026: Eight medicines recommended for approval and Wegovy goes oral
health1 month ago

CHMP May 2026: Eight medicines recommended for approval and Wegovy goes oral

EMA’s CHMP in May 2026 recommended eight new medicines (including Jascayd for IPF/PPF), three hybrid medicines, and a positive biosimilar opinion for Vislyfa; it issued a negative opinion for Deqtynet, approved extensions of indications for several medicines, and withdrew initial authorisation applications for Orblid and Veblocema. The committee also endorsed Wegovy’s extension to a daily oral tablet and published accompanying updates and statistics (eight positive opinions on new medicines, one negative, and eighteen positive opinions on extensions in 2026).

via European Medicines Agency (EMA)|
#chmp#drug-approval#ema
Biotech investors wary as FDA shifts stance on rare-disease drugs
business4 months ago

Biotech investors wary as FDA shifts stance on rare-disease drugs

Over the past year the FDA has denied or discouraged at least eight drug applications, including UniQure’s Huntington’s gene therapy and Regenxbio’s Hunter syndrome, and even reversed course on Moderna’s flu vaccine review, prompting investors to doubt whether the agency’s rare-disease flexibility will endure and to worry about the fate of other pipeline drugs; upcoming decisions (e.g., Denali Therapeutics) will test whether current standards remain consistent amid broader regulatory uncertainty.

via CNBC|
#biotech#business#drug-approval
FDA reversal sinks rare-disease cell therapy after favorable reviews
healthcare4 months ago

FDA reversal sinks rare-disease cell therapy after favorable reviews

An experimental cell therapy for a rare post-transplant blood cancer, developed by Atara Biotherapeutics and Pierre Fabre, was on track for FDA approval after internal reviewers recommended clearance, but the agency unexpectedly rejected it last month, citing deficient clinical data. Anonymous former agency sources say the decision may reflect leadership changes, marking a sharp reversal that disrupts a treatment expected to help roughly 500 patients in the US each year with a grim prognosis.

via statnews.com|
#biotech#drug-approval#fda
FDA Grants First Priority Review Vouchers to Nine Drugs
health8 months ago

FDA Grants First Priority Review Vouchers to Nine Drugs

The FDA announced the first nine recipients of the Commissioner’s National Priority Review vouchers, which expedite drug reviews for products aligned with national health priorities. Notably, EMD Serono received a voucher after agreeing to lower prices for its fertility drugs, including Pergoveris, in a move highlighted by President Trump. The program aims to incentivize companies to develop and provide access to important medications.

via statnews.com|
#drug-approval#emd-serono#fda
FDA Under Trump Moves Away from Expert Drug Reviews
health10 months ago

FDA Under Trump Moves Away from Expert Drug Reviews

Under the Trump administration, the FDA is moving to eliminate the practice of consulting outside experts for drug reviews, arguing it saves time and resources, but critics say it reduces transparency and public trust in drug approval decisions. The agency plans to rely more on complete response letters and internal reviews, sparking concerns about the loss of public and expert input in the regulatory process.

via KFF Health News|
#drug-approval#expert-reviews#fda
AstraZeneca and Baxdrostat unveil promising new treatments for resistant hypertension
health10 months ago

AstraZeneca and Baxdrostat unveil promising new treatments for resistant hypertension

AstraZeneca plans to seek regulatory approval for its experimental blood pressure drug, baxdrostat, by the end of the year, aiming for potential approval in 2026 in the US and EU. The drug targets the hormone aldosterone and has shown promising results in reducing systolic blood pressure, with peak sales expected to exceed $5 billion. A small percentage of patients experienced hyperkalaemia.

via Reuters|
#astrazeneca#baxdrostat#blood-pressure